{ "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": "2955842-2022-12821", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220707", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20220606", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20220707", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211202", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2672546", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220707", "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": "L90211204", "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)L90211204", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Arcing", "Material Split, Cut or Torn", "Arcing", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/12/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250807", "health_professional": "", "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": "20220707", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Hemorrhage/Blood Loss/Bleeding", "Burn(s)", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20220607", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14948470", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220607", "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": "295450967", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE DAMAGE TO THE MCS TIP COVER ACCESSORY PRIOR TO THE ARCING INCIDENT WAS LIKELY ATTRIBUTED TO COLLISION OF THE PROGRASP FORCEPS INSTRUMENT WITH THE MCS INSTRUMENT, WHICH CONSTITUTES USE ERROR. FAILURE ANALYSIS OF THE MCS TIP COVER ACCESSORY SHOWS TEARS DUE TO MISHANDLING/MISUSE. ISI HAS NOT RECEIVED THE MCS INSTRUMENT INVOLVED WITH THIS COMPLAINT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE MCS INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS RECEIVED THE MCS TIP COVER ACCESSORY ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE MCS TIP COVER ACCESSORY WAS FOUND TO HAVE TEARING ON THE DISTAL END. THE TEARS ARE AXIALLY ALIGNED WITH THE MCS TIP COVER ACCESSORY AND MEASURE FROM 0.225¿ TO 0.082¿ IN LENGTH. THERE ARE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY OF THE TEARS. THE ROOT CAUSE OF GOUGE(S) ON THE MCS TIP COVER ACCESSORY IS ATTRIBUTED TO MISHANDLING/MISUSE. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, ARCING FROM THE MCS INSTRUMENT WAS OBSERVED WHILE THE SURGEON WAS PERFORMING LYMPH NODE DISSECTION. THE EXTERNAL ILIAC ARTERY, WHICH WAS IN CONTACT WITH THE ELECTRICAL LEAKAGE SITE WAS INJURED, RESULTING IN ARTERIAL BLEEDING. THE BLEEDING POINT WAS SUTURED. THE SURGEON REPLACED THE MCS TIP COVER ACCESSORY AND USED THE SAME MCS INSTRUMENT TO COMPLETE THE PROCEDURE ROBOTICALLY." }, { "mdr_text_key": "295450968", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, ARCING WAS OBSERVED FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE EXTERNAL ILIAC ARTERY, WHICH WAS IN CONTACT WITH THE ELECTRICAL LEAKAGE SITE WAS INJURED, RESULTING IN ARTERIAL BLEEDING. THE BLEEDING POINT WAS SUTURED AFTER CLAMPING THE ARTERY. THE VIDEO OF THE PROCEDURE WAS REVIEWED BY THE SURGEON AND SHOWED THAT A FEW MINUTES BEFORE THE MCS TIP COVER ACCESSORY WAS FOUND TO BE TORN, THE WRIST OF THE MCS INSTRUMENT WAS OBSERVED TO BE SEVERELY BENT AND COLLIDED WITH A PROGRASP FORCEPS INSTRUMENT WHICH WAS OUT OF VIEW FROM THE SURGICAL FIELD. ALSO, AFTER THE ARCING INCIDENT, THE MCS TIP COVER ACCESSORY WAS REMOVED AND UPON EXAMINATION, THERE WERE MULTIPLE HOLES SEEN ON THE MCS TIP COVER ACCESSORY.INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE CANNULA, MCS INSTRUMENT, AND MCS TIP COVER ACCESSORY WERE INSPECTED BEFORE USE AND THERE WAS NO ABNORMALITY FOUND. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE CASE. THE MCS INSTRUMENT WAS IN USE FOR ABOUT 1 HOUR BEFORE THE ARCING OCCURRED. ARCING ORIGINATED FROM THE DAMAGED LOCATION OF THE TIP COVER (NEAR THE WRIST OF THE INSTRUMENT) AND GROUNDED ON THE EXTERNAL ILIAC ARTERY WHICH WAS IN CONTACT WITH THE DAMAGED PART OF THE TIP COVER. MONOPOLAR COAGULATION WAS ACTIVATED WHEN THE ARCING EVENT OCCURRED. THE GENERATOR USED WAS AN ERBE VIO DV AND ITS SETTINGS WERE UNKNOWN. THE PROGRASP FORCEPS AND FENESTRATED BIPOLAR FORCEPS (FBF) WERE THE OTHER INSTRUMENTS IN USE DURING THE ARCING INCIDENT. THERE WERE NO OTHER COLLISIONS OF THE MCS INSTRUMENT WITH OTHER INSTRUMENTS. THE MCS INSTRUMENT WAS NOT IN CONTACT WITH ANY STAPLES/CLIPS/SUTURES DURING THE ARCING EVENT. ADDITIONALLY, THE INSTRUMENT'S JAWS WERE NOT IMMERSED IN LIQUID OR CONTAMINATED BY CARBONIZED TISSUE. THE GROUNDING PAD WAS PLACED ON THE THIGH AND DID NOT HAVE ANY DEFECTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE SAME MCS INSTRUMENT INSTALLED AND WITH A NEW MCS TIP COVER ACCESSORY. THE AMOUNT OF BLEEDING WAS NOT PROVIDED AND THE PATIENT WAS NOT TRANSFUSED WITH BLOOD. VIDEO/IMAGES ARE NOT AVAILABLE TO ISI FOR REVIEW." }, { "mdr_text_key": "331241184", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATION INFORMATION CAN BE FOUND IN SECTION H10. ON 12-JUL-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM FAILURE ANALYSIS OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT): FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. A VISUAL INSPECTION OF THE INSTRUMENT FOUND NO PHYSICAL OR COSMETIC DAMAGE ON THE DISTAL END. NO SIGNS OF THERMAL DAMAGE WERE OBSERVED AT THE DISTAL END. THE HOUSING WAS REMOVED FROM THE BACK END AND NO DAMAGE WAS FOUND. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED AND PASSED. AN ENERGY DELIVERY TEST AND CUT TEST WERE BOTH PERFORMED WHILE THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND PASSED. THERE WAS NO PROBLEM DETECTED." }, { "mdr_text_key": "331241185", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "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": "08/09/2022" } ] }