{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2021-11291", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20211011", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210902", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20211011", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20140919", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1507469", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211011", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-14", "catalog_number": "400180", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20211006", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Arcing", "Material Fragmentation", "Arcing" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/07/2021;10/07/2021;09/17/2021;09/16/2021", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250807", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20211011", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "67 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions", "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210916", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12603878", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210916", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "328491622", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "328491623", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 17-SEP-2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT # (B)(4)STATING: \"DURING ROBOTIC THORACIC PROCEDURE, TIP OF MONOPOLAR CURVED SCISSOR SPARKED AND CAUGHT FIRE WHILE IN THORACIC CAVITY FOR APPROXIMATELY 3 SECONDS. SURGEON PULLED BACK ON INSTRUMENT TO IMMEDIATELY REMOVE FROM CAVITY AND FIRE EXTINGUISHED ON ITS OWN. FIRE DID NOT AFFECT/BURN ANY SURROUNDING TISSUE.\"" }, { "mdr_text_key": "326688396", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND THE MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT FOR ADVANCED FAILURE ANALYSIS (AFA). BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI RECEIVED THE MCS TIP COVER ACCESSORY (PN: 400180-14) INVOLVED WITH THIS COMPLAINT AND COMPLETED ADVANCED FAILURE ANALYSIS (AFA) DEVICE EVALUATION. THE TIP COVER WAS INSPECTED AND CONFIRMED THAT NEARLY ALL OF THE SILICONE SECTION AT THE DISTAL END HAD BEEN BURNED AWAY. THE PELLETHANE SECTION OF THE TIP COVER EXHIBITED MELTING AT ONE END. THE TIP COVER WAS INSTALLED ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT THAT WAS RETURNED WITH IT AND WHEN THE MCS WAS FULLY INSTALLED, THE DISTAL IDLER PULLEYS AND PART OF THE DISTAL CLEVIS WERE EXPOSED/NOT COVERED BY THE TIP COVER AS A RESULT OF THE THERMAL DAMAGE. THE TIP COVER WAS SLICED OPEN TO CHECK PELLETHANE INNER SURFACE FOR DAMAGE AND NO OBVIOUS SIGNS OF MELTING WERE OBSERVED ON THE INNER SURFACE. THERE WAS NO DAMAGE ON THE PELLETHANE THAT WOULD INDICATE THE THERMAL DAMAGE INITIATED FROM THE MCS INSTRUMENT, AND WENT OUTWARDS THROUGH THE PELLETHANE WALL THICKNESS, INSTEAD, THE EVIDENCE SUGGESTS THE THERMAL DAMAGE WAS INITIATED ON THE SILICONE SECTION AND MOVED PROXIMALLY TO THE PELLETHANE SECTION. THERE WAS NO OBVIOUS EVIDENCE ON THE RETURNED PIECE OF THE TIP COVER THAT SUGGESTS THAT A DEFECT IN THE TIP COVER CONTRIBUTED TO THE THERMAL DAMAGE. ISI RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT (PN: 470179-19 // LN: N12200427 0394) INVOLVED WITH THIS COMPLAINT AND COMPLETED ADVANCED FAILURE ANALYSIS (AFA) DEVICE EVALUATION. VISUAL INSPECTION CONFIRMED MELTED PIECES OF THE TIP COVER ARE STUCK TO DISTAL END COMPONENTS. THE INSTRUMENT WAS CHECKED FOR ELECTRICAL CONTINUITY AND PASSED. THE HOUSING WAS REMOVED AND NO VISIBLE DAMAGE WAS OBSERVED ON THE CONDUCTOR WIRE. THERE IS NO EVIDENCE OF ANY DEFECT ON THE INSTRUMENT THAT WOULD HAVE CONTRIBUTED TO THE INSTRUMENT SPARKING AND CAUSING THE TIP COVER TO CATCH FIRE." }, { "mdr_text_key": "326688397", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "326690796", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATION INFORMATION CAN BE FOUND IN SECTIONS H6 AND H10.   D11 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND THE MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT FOR FAILURE ANALYSIS. ISI RECEIVED THE MCS TIP COVER ACCESSORY (PN: 400180-14) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) CONCLUDED THAT THE REPORTED FAILURE WAS REPLICATED/CONFIRMED. THE DISTAL END OF THE ACCESSORY EXHIBITED LOCALIZED MELTING, WHICH IS INDICATIVE OF ARCING. MISSING MATERIAL WAS OBSERVED, MEASURING APPROXIMATELY 0.324\" X 0.618\". FA WAS UNABLE TO PROPERLY INSTALL THE MCS TIP COVER ACCESSORY ONTO AN IN-HOUSE INSTRUMENT DUE TO THE RETURNED CONDITION OF THE ACCESSORY. THE ROOT CAUSE OF THERMAL DAMAGE TIP COVER-ACCESSORY IS TYPICALLY ATTRIBUTED TO USER MISHANDLING.   ISI RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT (PN: 470179-19 // LN: N12200427 0394) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) CONCLUDED THAT THE REPORTED FAILURE WAS CONFIRMED BUT NOT REPLICATED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND IT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS AND THE GRIPS/TIPS (FOR SCISSORS) OPENED AND CLOSED PROPERLY. ENERGY DELIVERY WAS PERFORMED AND NO ARCING WAS OBSERVED DURING IN-HOUSE TESTING. ELECTRICAL CONTINUITY WAS PERFORMED AND PASSED. THERE WAS NO TROUBLE FOUND WITH THE INSTRUMENT'S FUNCTIONALITY. HOWEVER, IT WAS OBSERVED THAT MELTED PARTS OF THE MCS TIP COVER ACCESSORY WERE FOUND AT THE DISTAL END OF THE INSTRUMENT ON THE DISTAL IDLER PULLEYS. NO THERMAL DAMAGE OR SIGNS OF ARCING WERE OBSERVED AT THE DISTAL END." }, { "mdr_text_key": "336863165", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336863166", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1 B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\" B2 UPDATED TO \"REQUIRED INTERVENTION\" H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"" }, { "mdr_text_key": "283408637", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. ISI HAS REQUESTED THE MCS INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION BUT AT THIS TIME, HAS NOT BEEN RETURNED TO ISI FOR ANALYSIS. IT WAS CONFIRMED BY SITE PERSONNEL THAT THE MCS TIP COVER ACCESSORY (AND/OR REMNANTS) IS NOT AVAILABLE FOR RETURN AS IT ¿WAS NOT SAVED AS IT WAS MOSTLY BURNED UP¿. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SITE HISTORY REVIEW WAS CONDUCTED AND FOUND NO OTHER COMPLAINTS FOR THIS PRODUCT. SYSTEM ERROR LOG REVIEW WAS CONDUCTED ON 18-SEPT-2021 FOR A PROCEDURE ON (B)(6) 2021 ON SYSTEM (B)(4). THERE WERE NO OBSERVED RELATED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. A REVIEW OF THE INSTRUMENT LOGS WAS ALSO PERFORMED. THERE WERE TWO MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENTS RECORDED DURING THE PROCEDURE AS FOLLOWS: MCS PN: 470179-19 // LN: N12200427-0394 WAS IN USE FOR 54 MINUTES, IT HAD 4 OF 10 USES REMAINING, AND IT HAS NOT BEEN USED IN A SUBSEQUENT PROCEDURE AT THIS TIME; MCS PN: 470179-19 // LN: N12210531-0193 WAS IN USE FOR 1 HOUR 27 MINUTES AND 54 SECONDS, IT HAD 8 OF 10 USES REMAINING, AND IT HAS NOT BEEN USED IN A SUBSEQUENT PROCEDURE AT THIS TIME. ALL OTHER, REUSABLE, INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES, SOME OF WHICH WERE USED THROUGH THEIR RESPECTIVE END OF USES AND AT THIS TIME, AND A SITE HISTORY SEARCH SHOWS NO COMPLAINTS FILED AGAINST THOSE INSTRUMENTS. AN ISI ADVANCED FAILURE ANALYST (AFA) ENGINEER CONDUCTED A SYSTEM LOG REVIEW AND FOUND THE FOLLOWING: THE FIRST MCS INSTRUMENT USED IN THIS PROCEDURE WAS SERIAL NUMBER 2004270394 [PN: 470179-19 // LN: N12200427-0394 // SN: (B)(4)]. THERE WERE NO OBSERVED RELATED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. IF WE ASSUME THAT THE ISSUE/EVENT OCCURRED AT AROUND THE TIME WHEN THE FIRST MCS INSTRUMENT WAS REMOVED, THERE ARE NO ERRORS IN THE LOGS AROUND THAT TIME. ADDITIONALLY, AN ISI AFA ENGINEER FOUND THE FOLLOWING RELATED TO MCS TIP COVER FUNCTIONAL REQUIREMENTS: THE TIP COVER IS DESIGNED TO MEET THE REQUIREMENTS SPECIFIED IN ITS FUNCTIONAL REQUIREMENTS DOCUMENT (PN 823111). THE FUNCTIONAL REQUIREMENTS CONTAIN MECHANICAL AND ELECTRICAL REQUIREMENTS FOR THE TIP COVER, AND VERIFICATION/VALIDATION TESTING HAS BEEN PERFORMED AS PART OF PRODUCT RELEASE ACTIVITIES TO CONFIRM THAT THE PRODUCT MEETS THE INTENDED REQUIREMENTS. A VIDEO CLIP FOR THE REPORTED EVENT WAS PROVIDED BY THE CUSTOMER, WAS SUBMITTED TO AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE) FOR CLINICAL VIDEO REVIEW, AND RESULTS WERE AS FOLLOWS: A SPARK WAS VISIBLE AT APPROXIMATELY 14 SECONDS INTO THE VIDEO. PRIOR TO THE VIDEO STARTING, THERE WAS LIKELY A LOT OF ENERGY ACTIVATION; INDICATED BY THE AMOUNT OF PLUME IN THE FIELD OF VIEW AND BY ESCHAR ON THE TISSUE AND ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. AT APPROXIMATELY 21 SECONDS, WE CAN SEE THE TIP COVER MOVE DUE TO MELTING, AND THE SURGEON BRINGS THE TIP COVER INTO THE FIELD OF VIEW. THE TIP COVER IS ON FIRE. THE SURGEON GRABS AT THE MCS TIP COVER WITH A CADIERE FORCEPS INSTRUMENT, AND SOME MELTED PIECES OF THE TIP COVER ARE OBSERVED DROPPING INTO THE PATIENT. ULTIMATELY, THE MCS INSTRUMENT IS REMOVED FROM THE PATIENT. THE PROCEDURE COMPLETED ROBOTICALLY WITH USE OF A BACKUP MCS INSTRUMENT AND THE SURGEON STATED THAT, EVEN WITH FLAMING REMNANTS OF AN MCS TIP COVER ACCESSORY LANDING ON PATIENT ANATOMY DURING THE PROCEDURE, THERE WAS NO PATIENT INJURY AND THAT NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT. WHILE THE SURGEON INDICATED THAT THERE WAS AN INTRA-OPERATIVE AIR LEAK DURING THE PROCEDURE, THE SURGEON SAID THAT NO MEDICAL INTERVENTION WAS REQUIRED. SINCE NO INTERVENTION WAS REQUIRED TO ADDRESS AN INTRA-OPERATIVE LEAK WITHIN THE SAME PROCEDURE, IT IS NOT CONSIDERED AS ¿MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT.¿ THEREFORE, THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE ADVERSE EVENT. THE DESCRIBED EVENT MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THE MCS TIP COVER ACCESSORY WAS DAMAGED DUE TO ARCING WITH NO INITIAL EVIDENCE OR CLAIM OF USER MISHANDLING/MISUSE. IN THE EVENT THE MCS TIP COVER ACCESSORY IS COMPROMISED, IT IS POSSIBLE FOR ENERGY TO DISCHARGE IN AN AREA OTHER THAN THE INSTRUMENT TIP. PER THE I&A USER MANUAL \"IT IS IMPORTANT TO EXERCISE CAUTION WHEN USING AN ENERGIZED ENDOWRIST MONOPOLAR CURVED SCISSORS INSTRUMENT TO HELP AVOID UNINTENDED CONTACT WITH TISSUE ADJACENT TO THE AREA TO BE CAUTERIZED.\" FAILURE TO FOLLOW THESE PRECAUTIONS WILL RESULT IN ELECTRICAL ARCS FROM THE WRIST AND ALTERNATE SITE BURNS. ADDITIONALLY, ALL FRAGMENTS WERE VISUALLY RETRIEVED DURING THE SAME PROCEDURE AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION." }, { "mdr_text_key": "283408638", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS INFORMED BY THE SURGEON THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE ON (B)(6) 2021, ¿THE SHEATH OF A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT CAUGHT FIRE DURING THE CASE¿. THE SURGEON WAS NOT NECESSARILY SURE IF THE ISSUE WAS CAUSED BY THE ISI PRODUCT OR NOT. THE SURGEON ASKED THE ISI REPRESENTATIVE IF ISI HAS SEEN THIS BEFORE. THE SURGEON DID NOT INDICATE THAT THEY BELIEVED THAT THE ISSUE WAS DUE TO A DEFECTIVE ISI PRODUCT. IT WAS UNCLEAR IF THE CUSTOMER PLANNED TO RETURN THE MCS INSTRUMENT OR MCS TIP COVER ACCESSORY TO ISI FOR ANALYSIS. IT WAS REPORTED THAT THERE MAY HAVE BEEN A SLIGHT DELAY DUE TO THIS ISSUE BUT THE SPECIFIC TIME OF DELAY WAS UNKNOWN. A VIDEO OF THE EVENT WAS OBTAINED FROM THE SURGEON WHICH APPEARS TO HAVE A MELTED SHEATH THAT POSSIBLY FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED WITHIN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 17-SEPT-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE CONSOLE SURGEON REGARDING THE REPORTED EVENT: DURING A PLEURAL DECORTICATION PROCEDURE ON (B)(6) 2021, THERE ¿WAS A SPARK¿ FROM AN MCS INSTRUMENT WHEN USING MONOPOLAR CAUTERY WHICH RESULTED IN ¿BURNING PLASTIC PIECES¿. THE SURGEON SAID THAT WHEN HE WENT TO USE THE MCS INSTRUMENT, THE PLASTIC PIECE CAUGHT FIRE. THE SURGEON SAID THAT HE BELIEVES THAT THE ISSUE OCCURRED BECAUSE ¿THE SOURCE OF THE O2 [OXYGEN] WAS NOT REALIZED¿. THE SOURCE WAS DESCRIBED AS ¿COMING FROM THE VENTILATOR¿. THE SURGEON STATED THAT THERE WAS ¿CO2 INTO THE PLURAL SPACE¿ WHICH WAS DESCRIBED AS ¿CARBON DIOXIDE IN THE WORKING SPACE¿. THE SURGEON SAID THAT THERE WERE NO OTHER PROBLEMS ¿ONCE THE O2 WAS REDUCED¿ AND ¿ONCE THE SOURCE OF THE IGNITION WAS REMOVED¿. THE SURGEON SUCCESSFULLY ¿WITHDREW THE INSTRUMENT¿ AND REPLACED IT WITH A BACKUP MCS INSTRUMENT. WHEN ASKING THE SURGEON ABOUT THE FLAMING PARTS THAT FELL INTO THE PATIENT, AND DID THEY LAND ON TISSUE CAUSING AN INJURY, THE SURGEON SAID NO. THE SURGEON SAID THAT ALL TIP COVER REMNANTS, EVEN THE LARGER PIECE, WERE EITHER ¿BURNT AWAY¿ OR WERE REMOVED FROM THE PATIENT BY UNSPECIFIED MEANS DURING THE PROCEDURE; THERE WERE ¿ONLY A COUPLE OF PIECES¿ LEFT TO RETRIEVE, CONFIRMED BY VISUAL INSPECTION. THE SURGEON DID NOT KNOW THE DIMENSIONS OF THE PIECES. THE AREA WAS CLEANSED AND ¿WASHED OUT¿ AND THE SURGEON SAID THAT THE ¿LUNG TISSUE AND THE PATIENT WERE FINE¿. WHEN ASKING THE SURGEON IF AN AIR LEAK TEST WOULD BE NEEDED OR APPLICABLE, THE SURGEON SAID THAT IT WAS NOT NECESSARY. THE AIR LEAK ¿STOPPED ON ITS OWN¿. THE SURGEON SAID THAT ¿A SMALL LEAK IS NOTHING TO WORRY ABOUT¿ AND THAT ¿IT HAPPENS ALL THE TIME¿. THE SURGEON SAID THAT SMALL AIR LEAKS TAKE CARE OF THEMSELVES. THE SURGEON SAID THAT NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO OTHER INTRA-OPERATIVE ISSUES AND NO PATIENT INJURY. THE SURGEON SAID THAT THE PATIENT WAS DISCHARGED HOME, THE ¿PATIENT IS FINE¿, THE PATIENT ¿WASN¿T INJURED OR ANYTHING¿, AND THERE HAVE BEEN NO POST-OPERATIVE COMPLICATIONS TO DATE. THE SURGEON SAID THAT THERE WERE NO SOLVENTS, ALCOHOL WIPES, OR LUBRICATION USED AT ALL. ANESTHESIA DETAIL AND/OR RECORDS WERE REQUESTED, ALONG WITH WHAT % OF O2 AT THE TIME, WAS THERE ANY BLOW-BACK OF O2 INTO THE SPACE, AND WAS THERE EXTERNAL INSUFFLATION; BUT THE SURGEON DECLINED PROVIDING THE INFORMATION. THE SURGEON SAID THAT THERE WAS BIO-DEBRIS AT THE TIP OF THE MCS INSTRUMENT; THE SURGEON SAID ¿THE SCISSORS HAD CHARRED TISSUE¿ ON THE TIPS AND ON THE ¿RUBBER PART¿. THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND THERE WERE NO ISSUES. ELECTROLUBE WAS NOT APPLIED. THE FOLLOWING QUESTIONS REMAIN UNKNOWN AS THE SURGEON SAID HE HAD TO GO AND THE CALL ENDED: WAS A MONOPOLAR CORD CONNECTED TO A BIPOLAR INSTRUMENT? WHAT TYPE OF GENERATOR/ELECTROSURGICAL UNIT (ESU) WAS USED? WHAT WERE THE SETTINGS USED ON THE GENERATOR/ESU (CUT/COAG)? HOW LONG WAS THE INSTRUMENT IN USE PRIOR TO THE ARCING EVENT? WHAT OTHER INSTRUMENTS WERE IN USE WHEN THE ARCING EVENT OCCURRED? DID THE INSTRUMENT TIPS EVER COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE? WAS THE INSTRUMENT REMOVED AT ANY TIME PRIOR TO THE EVENT? WAS A GROUNDING PAD IN USE? IF SO, WHERE ON THE PATIENT WAS IT PLACED? DID THE GROUNDING PAD APPEAR TO HAVE ANY ISSUES/DEFECTS? HOW WERE THE FRAGMENTS RETRIEVED? WERE THERE ANY POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS?" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/13/2021;10/15/2021;02/19/2022;05/24/2023" } ] }