{ "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": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SUNNYVALE", "manufacturer_contact_address_1": "1266 KIFER ROAD, BLDG 101", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2012-00439", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20120914", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20120824", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94086", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "REED", "source_type": [ "Health Professional", "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94086", "manufacturer_g1_state": "CA", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120917", "manufacturer_contact_f_name": "TABITHA", "device_date_of_manufacturer": "20101101", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120914", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS3000 A6.0P7", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20120915", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Degraded" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/17/2012;10/17/2012", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20120914", "sequence_number_treatment": [ "DA VINCI SI SYS, INSTRUMENTS, ACCESSORIES AND ESU", " DA VINCI SI SYS, INSTRUMENTS, ACCESSORIES AND ESU" ], "sequence_number_outcome": [ "Other" ], "patient_age": "52 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20121017", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SUNNYVALE", "mdr_report_key": "2746240", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120824", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94086", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "3118589", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A TRANSORAL ROBOTIC SURGERY(TORS) PROCEDURE, USING THE DA VINCI SI SURGICAL SYSTEM, IT WAS NOTED THAT THE PATIENT SUSTAINED A BURN ON THE LIP. THE MONOPOLAR CAUTERY INSTRUMENT WAS INSPECTED AND IT WAS NOTICED THAT THERE WAS A WEAK AREA IN THE BLACK INSULATION. IT IS BELIEVED THIS AREA MAY HAVE CAUSED ENERGY TO BE RELEASED, AND MAY HAVE CAUSED THE BURN. THE PATIENT WAS TREATED USING OINTMENT AND IS EXPECTED TO MAKE A FULL RECOVERY." }, { "mdr_text_key": "10182097", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MONOPOLAR CAUTERY INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. THE ROOT CAUSE OF THE SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT IS ALSO CURRENTLY UNDETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE INSTRUMENT IS RETURNED. AS OF SEPTEMBER 13, 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL." }, { "mdr_text_key": "173071700", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, INTUITIVE SURGICAL CONTACTED THE CLINICAL SALES REPRESENTATIVE THAT WAS PRESENT DURING THE SURGICAL PROCEDURE AND HE INDICATED THAT A CAUTERY SPATULA TIP ACCESSORY WAS INSTALLED ON THE 5MM MONOPOLAR CAUTERY INSTRUMENT AND THAT INSPECTION OF THE CAUTERY SPATULA TIP ACCESSORY BY THE SITE FOUND NO DAMAGE. THE CSR INDICATED THAT FURTHER INVESTIGATION FOUND THAT AN 8MM CANNULA WAS USED IN CONJUNCTION WITH THE CAUTERY INSTRUMENTS DURING THE SURGICAL PROCEDURE AND THAT THE BURN SUSTAINED BY THE PATIENT WAS LIKELY DUE TO THE SITE'S USE OF THE 8 MM CANNULA, WHICH IS NOT GROUNDED. THE CSR INDICATED THAT HE HAS REMINDED THE SURGEON THAT HE SHOULD FOLLOW THE DA VINCI TORS PROCEDURE GUIDE RECOMMENDATION TO USE THE 5MM FLARED CANNULA. ON (B)(6) 2012, INTUITIVE SURGICAL CONTACTED DR (B)(6), THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE AND HE INDICATED THAT DURING THE SURGICAL PROCEDURE A 8MM CANNULA WAS USED IN CONJUNCTION WITH A MONOPOLAR CAUTERY INSTRUMENT DR HOFF INDICATED THAT HE RECALLS THAT THE 5MM MONOPOLAR CAUTERY INSTRUMENT RUBBED AGAINST THE CANNULA, CAUSING DAMAGE TO THE TUBE INSULATION AND THAT THE CANNULA WAS RESTING AGAINST THE PATIENT'S LIP AND THAT IT IS HIS BELIEF THAT THE BUM INJURY SUSTAINED BY THE PATIENT WAS LIKELY CAUSED BY THE CANNULA SINCE THE CANNULA WAS RESTING ON THE PATIENT'S LIP. DR (B)(6) INDICATED THAT THE PATIENT SUSTAINED FIRST DEGREE BURNS THAT DID NOT REQUIRE ANY SURGICAL INTERVENTION AND OINTMENT WAS USED TO TREAT THE PATIENT. DR (B)(6) INDICATED THAT AS OF (B)(6) 2012, THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. DR (B)(6) ALSO INDICATED THAT THE SITE IS NOW USING THE 5MM FLARED CANNULA IN CONJUNCTION WITH THE ENDOWRIST 5MM INSTRUMENTS DURING DA VINCI SI TORS PROCEDURES. THE 5MM MONOPOLAR CAUTERY INSTRUMENT WAS RETURNED AND EVALUATED ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED FAILURE MODE AS INSPECTION OF THE INSTRUMENT'S MAIN TUBE FOUND NO EVIDENCE OF ARCING. THE INSTRUMENT DID NOT EXHIBIT MELTING OR CHAR MARKS ON THE MAIN TUBE OR ON ANY OF THE DISTAL END COMPONENTS. THE CONDUCTOR WIRE IS NOT DAMAGED AT THE DISTAL END AND THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. THE INSTRUMENT PASSED FUNCTIONAL TESTING WITH AN IN-HOUSE CAUTERY SPATULA TIP ACCESSORY INSTALLED, A MONOPOLAR CAUTERY CORD AND A VALLEY LAB ELECTRICAL SURGICAL UNIT ARCING WAS NOT OBSERVED INTUITIVE SURGICAL'S INVESTIGATION INTO THE REPORTED EVENT HAS CONCLUDED THAT THE 8 MM CANNULA LIKELY CAUSED THE BURN INJURY SUSTAINED BY THE PATIENT AS A RESULT OF CAPACITIVE COUPLING THAT CAN OCCUR WHEN USING A CANNULA THAT IS NOT GROUNDED PROPERLY. THE TORS PROCEDURE REFERENCE GUIDE RECOMMENDS THAT THE 5MM FLARED CANNULA BE USED IN CONJUNCTION WITH THE ENDOWRIST 5MM CAUTERY INSTRUMENTS DURING DA VINCI SI SURGICAL PROCEDURES. THE CSR HAS ADVISED SITE THAT THE SITE THAT THE 5MM FLARED CANNULA IS RECOMMENDED FOR DA VINCI SI TRANSORAL (TORS) SURGICAL PROCEDURES AS INDICATED IN INTUITIVE SURGICAL'S TORS PROCEDURE GUIDE AND THAT THE SITE HAS ORDERED THE FLARED CANNULA AND THE SITE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1266 KIFER ROAD, BLDG 101", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94086", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/17/2012;10/27/2012" } ] }