{ "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": "2955842-2022-10233", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220211", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20211228", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "PO", "manufacturer_contact_area_code": "408", "date_added": "20220211", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210624", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "883845", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220211", "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": "L90210625", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)L90210625", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Thermal Decomposition of Device", "Arcing", "Material Split, Cut or Torn", "Thermal Decomposition of Device", "Arcing", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/26/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20220211", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "86 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Burn", "Bowel Burn" ] } ], "distributor_city": "", "date_report": "20220117", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13518750", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220117", "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": "293346992", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO DEVICE MANUFACTUER NARRATIVE FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "293346993", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE REPORTED THERMAL DAMAGE. THE DISTAL END OF THE MCS TIP COVER ACCESSORY EXHIBITED MELTING, WHICH IS INDICATIVE OF ARCING. THE SITE ALSO RETURNED THE MCS INSTRUMENT THAT WAS USED IN CONJUNCTION WITH THE MCS TIP COVER ACCESSORY. THE MCS INSTRUMENT DID NOT EXHIBIT ANY CHAR MARKS OR THERMAL DAMAGE. THE MCS TIP COVER ACCESSORY HAS A POTENTIAL HARM CONCERN OF POTENTIAL FRAGMENTS. THE ROOT CAUSE OF THERMAL DAMAGE TO A MCS TIP COVER ACCESSORY IS TYPICALLY ATTRIBUTED TO THE USER. FROM THE VIDEO RECORDING OF THE INCIDENT, IT WAS SEEN THAT AS THE SURGEON ACTIVATED ENERGY ON THE MCS INSTRUMENT, THERE WAS ARCING BETWEEN A BIPOLAR INSTRUMENT AND THE WRIST OF THE MCS INSTRUMENT WHICH WAS COVERED BY THE MCS TIP COVER ACCESSORY. THE SILICON PART OF THE MCS TIP COVER ACCESSORY THEN CAUGHT FIRE AND MELTED. THIS INCIDENT WAS ATTEMPTED TO BE REPLICATED WITH A NEW MCS TIP COVER ACCESSORY ON THE RETURNED MCS INSTRUMENT BY MANIPULATING THE WRIST SO THAT ONLY THE MCS TIP COVER ACCESSORY PORTION AND NOT THE GRIP TIPS WAS TOUCHING A TEST SPONGE. ENERGY WAS ACTIVATED ON THE MAX POWER LEVEL AND THERE WAS NO THERMAL DAMAGE OBSERVED TO THE TIP COVER. THIS INDICATES THAT THE MELTING/THERMAL DAMAGE OBSERVED ON THE MCS TIP COVER ACCESSORY WAS LIKELY NOT DUE TO DEFECTIVE MCS INSTRUMENT. ADDITIONAL TESTING WAS PERFORMED IN WHICH THE RETURNED MCS TIP COVER ACCESSORY'S SILICONE AND PELLETHANE PORTIONS WERE TESTED AND COMPARED TO THE SILICONE AND PELLETHANE PORTIONS OF A GOOD MCS TIP COVER ACCESSORY. THE RESULTS SHOW THAT, FOR BOTH THE SILICONE AND PELLETHANE TESTS, THE INCIDENT MCS TIP COVER ACCESSORY'S SPECTRUM MATCHES THE SPECTRUM OF THE GOOD/UNUSED MCS TIP COVER ACCESSORY. THIS INDICATES THAT THE MCS TIP COVER ACCESSORY WAS CONFORMING IN ITS MATERIAL MAKEUP. A REVIEW OF THE VIDEO RECORDING WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL DEVELOPMENT ENGINEER (CDE), AND THE FOLLOWING INFORMATION WAS PROVIDED: THERE WAS ARCING BETWEEN THE BIPOLAR INSTRUMENT AND THE WRIST OF THE MCS INSTRUMENT (COVERED BY THE TIP COVER) AS THE SURGEON ACTIVATES ENERGY WITH THE MCS INSTRUMENT. THE BURN ON THE TIP COVER PROPAGATES, THEN THE SURGEON MOVES THE MCS AWAY FROM TISSUE BEFORE IT IS REMOVED FROM THE SURGICAL FIELD. THE CDE DID NOT OBSERVE ANY THERMAL EFFECT TO NEARBY TISSUE AS A RESULT OF THE TIP COVER BURNING. THE CDE ALSO DID NOT OBSERVE ANY PIECES OF THE MCS TIP COVER ACCESSORY MELTING OFF AND FALLING INTO THE PATIENT. ON REVIEW OF THE LONGER VIDEO RECORDING, IT DOES LOOK LIKE THERE IS SOME SORT OF LINGERING FLAMES ON THE BOTTOM LEFT OF THE SCREEN AT THE 28 SECOND MARK AFTER THE MCS INSTRUMENT IS REMOVED. IT IS UNCLEAR IF THIS IS FROM MATERIAL THAT SLOUGHED OFF THE MCS TIP COVER ACCESSORY AS IT WAS BEING REMOVED OR FROM IGNITING ANY OXYGEN IN THE WORKSPACE. THE VIDEO THEN SHOWS THE SURGEON INSPECT THE WORKSPACE AND COLLECT ANY DEBRIS THAT MIGHT HAVE FALLEN INSIDE THE PATIENT OR TRANSFERRED TO THE BIPOLAR INSTRUMENT. AN ASSIST USES SUCTION TO REMOVE THE DEBRIS AS MUCH AS POSSIBLE. CLINICAL LAB INVESTIGATION WAS CARRIED OUT BY AN ISI CDE AND THE FOLLOWING FINDINGS WERE OBTAINED: LAB PERFORMED IN A PORCINE MODEL, INSUFFLATED WITH AIRSEAL. MCS INSTRUMENT FROM DECEMBER EVENT USED AS WELL AS FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT ENERGY SETTINGS USED: SWIFT COAG 4, FORCED COAG 4, SWIFT COAG 8. ARCING INDUCED WITH MESENTERIC TISSUE AND GAUZE IN GRIPS OF FBF INSTRUMENT. FLAMES/PLASMA OBSERVED WITH CHAR INDUCED ON GAUZE AND TISSUE. FLAME DID NOT SPREAD ON MCS TIP COVER ACCESSORY OR GAUZE (SUPPRESSED IMMEDIATELY IN CO2 SATURATED ENVIRONMENT) RESULTS: THE INCIDENT OF FLAME SPREADING ACROSS THE MCS TIP COVER ACCESSORY COULD NOT BE REPLICATED/CONFIRMED. ISI FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION: THE SITE CONFIRMED THAT THEY HAD USED REGULAR AIR INSTEAD OF CO2 FOR INSUFFLATION. THE OUTLET WITH REGULAR AIR IS OUT OF USE FOR NOW AND THE SITE IS USING ANOTHER OUTLET IN THE SAME ROOM WITH CO2. THE SITE USES AIR SEAL CANNULAS FOR INSUFFLATION, AS WELL AS 5MM CANNULA FOR ASPIRATION AND A PORT FOR LIVER RETRACTORS (REUSABLE CANNULAS). NEUTRAL PADS GENERALLY PLACED ON LEG (INNER THIGH) AND SITE RARELY USES 2 PADS AT ONCE. THE HOSPITAL IS NEW (ABOUT 1.5 YEARS OLD) AND HAS BEEN USING THE DA VINCI SYSTEM THROUGHOUT. THE HOSPITAL KEEPS TO REGULAR MAINTENANCE SCHEDULE FOR SYSTEM. A REVIEW OF THE EVENT INFORMATION WAS PERFORMED BY A CDE AND THE FOLLOWING FINDINGS WERE OBTAINED: IN THIS CASE, THE PRESENCE OF OXYGEN, SUCH AS IN ROOM AIR, DURING PNEUMOPERITONEUM INCREASED THE RISK OF COMBUSTION AND PROVIDED FUEL FOR THE FLAMES TO SPREAD ON THE MCS TIP COVER ACCESSORY. THIS IS WHY THE MEDICAL STANDARD IS TO USE CARBON DIOXIDE FOR PNEUMOPERITONEUM AS IT IS NON-COMBUSTIBLE AND SUPPRESSES ANY FLAMES THAT MAY OCCUR." }, { "mdr_text_key": "285523803", "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 AND INTRA-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. NEITHER THE MCS INSTRUMENT NOR THE MCS TIP COVER ACCESSORY HAVE BEEN RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF IMAGES PROVIDED BY THE CUSTOMER WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THESE IMAGES SEEM TO SHOW THAT SOME ENERGY COMING FORM THE MCS MANAGED TO CAUSE THERMAL DAMAGE TO THE MCS TIP COVER ACCESSORY FROM THE INSIDE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF THE SITE'S COMPLAINT HISTORY SHOWED NO OTHER COMPLAINTS FOR THE MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED HEMICOLECTOMY SURGICAL PROCEDURE, THE MCS INSTRUMENT ALLEGEDLY ARCED AND THE MCS TIP COVER ACCESSORY BURNED AT ITS TIP. THE MCS INSTRUMENT WAS REMOVED IMMEDIATELY, BUT PORTIONS OF THE BURNT MCS TIP COVER ACCESSORY FELL ON HEALTHY BOWEL WHICH CAUSED BURNT LESIONS. AS A RESULT, THE SURGEON HAD TO REMOVE THAT PORTION OF THE DAMAGED BOWEL AND PERFORM ADDITIONAL UNPLANNED ANASTOMOSES WITH MECHANICAL STAPLING. THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND INTRA-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. PMA/510(K) NUMBER AND ADVERSE EVENT ARE NOT APPLICABLE." }, { "mdr_text_key": "285523804", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEMICOLECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT WAS BURNED AT ITS TIP. THE MCS INSTRUMENT WAS REMOVED IMMEDIATELY, BUT PORTIONS OF THE BURNT MCS TIP COVER ACCESSORY FELL ON HEALTHY BOWEL AND ALLEGEDLY CAUSED BURNT LESIONS THAT HAD TO BE REMOVED, AND HEALTHY BOWEL RECONNECTED. THE PROCEDURE WAS COMPLETED WITH A BACKUP MCS. THE ISSUE LED TO A PROCEDURE DELAY OF 30 MINUTES OR GREATER. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING INITIAL TISSUE DISSECTION, ABOUT TEN MINUTES INTO THE PROCEDURE, ARCING WAS WITNESSED BETWEEN THE MCS AND A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. IT WAS STATED THAT THE FENESTRATED BIPOLAR FORCEPS WAS IN CONTACT WITH THE TISSUE AND NOT THE MCS INSTRUMENT WHEN ARCING OCCURRED. THE ARCING ORIGINATED FROM THE MCS INSTRUMENT, AND THE SITE IDENTIFIED A DAMAGED MCS TIP COVER ACCESSORY. THE MCS INSTRUMENT WAS REMOVED; HOWEVER, THE INCINERATED FRAGMENTS OF THE MCS TIP COVER ACCESSORY FELL ONTO THE HEALTHY BOWEL AND BURNT THE TISSUE. AS A RESULT, THE SURGEON HAD TO REMOVE THAT PORTION OF THE DAMAGED BOWEL AND PERFORM ADDITIONAL UNPLANNED ANASTOMOSES WITH MECHANICAL STAPLING. THE MELTED PIECES OF THE MCS TIP COVER ACCESSORY WERE REMOVED WITH A GRASPER. THE INSTRUMENT AND ACCESSORIES WERE INSPECTED BEFORE USE AND THERE WAS NO DAMAGE NOTED. THERE WERE NO INSTRUMENT COLLISIONS AND NO CONTACT WITH CLIPS OR STAPLES. THERE WAS NO CARBONIZED TISSUE AT INSTRUMENT TIPS, NOR WERE THEY IMMERSED IN LIQUID. THE INSTRUMENT WAS NOT REMOVED PRIOR TO THE ARCING EVENT, AND THE SITE CONNECTED THE BIPOLAR AND MONOPOLAR CORDS CORRECTLY. THE GENERATOR USED DURING THE PROCEDURE WAS AN ERBE VIO DV, AND THE SETTINGS WERE AT CUT: 3 OR 4 AND COAG: 3 OR 4. AS OF THE DATE OF THIS REPORT, THE PATIENT IS REPORTED TO BE RECOVERING WELL." } ], "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": "05/25/2022" } ] }