{ "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": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2015-01101", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20150813", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150707", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150813", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "534126", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150813", "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 A6.0P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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": [ "Use of Incorrect Control/Treatment Settings", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "health_professional": "", "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": "20150813", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20150716", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5000516", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150716", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "22866078", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION FROM THE SURGEON THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A MULTI-PORT DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS FOUND TO HAVE SUSTAINED A DELAYED THERMAL BURN INJURY TO A URETER THAT REQUIRED REPAIR. HOWEVER, THE CAUSE OF THE PATIENT'S URETER INJURY IS UNKNOWN. NOTE: THIS MDR IS BEING SUBMITTED FOR EVENT 3 OF THE 3 REPORTED POST-OPERATIVE THERMAL BURN INJURY EVENTS. REFER TO THE MFR REPORTS WITH PATIENT IDENTIFIERS (B)(6) FOR INFORMATION REGARDING THE OTHER 2 REPORTED POST-OPERATIVE THERMAL BURN INJURY EVENTS." }, { "mdr_text_key": "22866079", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS MDR RELATES TO ONE OF THREE SIMILAR EVENTS THAT WERE REPORTED TOGETHER. SPECIFICALLY, IT WAS REPORTED THAT 3 DIFFERENT PATIENTS, EACH OF WHOM HAD A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED BY THE SAME SURGEON ON DIFFERENT DAYS WITHIN A 6-WEEK PERIOD, RETURNED TO THE HOSPITAL AN UNSPECIFIED NUMBER OF DAYS POST-OPERATIVELY AND WERE FOUND TO HAVE SUSTAINED POST-OPERATIVE THERMAL BURN INJURIES TO A URETER. ON 08/05/2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON STATED THAT ON (B)(6) 2015, HE PERFORMED A MULTI-PORT DA VINCI HYSTERECTOMY PROCEDURE. HE INDICATED THAT NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS REPORTED. AT THE END OF THE DA VINCI SURGICAL PROCEDURE, THE SURGEON INDICATED THAT HE HAD PERFORMED A CYSTOSCOPY AND BOTH URETERS WERE FOUND TO BE PULSING NORMALLY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT CAME BACK TO THE HOSPITAL AND A THERMAL BURN INJURY WAS FOUND ON ONE OF THE URETERS CLOSE TO WHERE THE URETER ENTERS THE BLADDER. A UROLOGIST REPAIRED THE URETERAL INJURY BY PLACING A NEPHROSTOMY TUBE. THE PATIENT WAS HOSPITALIZED FOR A FEW DAYS AND THEN DISCHARGED. THE SURGEON BELIEVES THAT THE URETER INJURY WAS A DELAYED THERMAL SPREAD INJURY. THE SURGEON ADMITTED, HOWEVER, THAT DURING THE TIME OF THE EVENTS, HIS REGULAR CIRCULATING NURSE HAD CHANGED AND THE NEW CIRCULATING NURSE HAD INADVERTENTLY SET THE ELECTROSURGICAL UNIT (ESU) SETTING TO 40. THE SPECIFIC TYPE OF ESU USED DURING THE PROCEDURE IS UNKNOWN. THE SURGEON STATED THAT HE NORMALLY PERFORMS HIS PROCEDURES WITH 25-30 ESU SETTINGS. DURING ONE OF THE THREE DA VINCI SURGICAL PROCEDURES, THE SURGEON NOTICED THAT THERE WAS MORE HEAT EFFECT ON TISSUE THAN ANTICIPATED WHILE USING AN UNSPECIFIED INSTRUMENT. HE ATTRIBUTED THE HIGHER THAN NORMAL ESU SETTING AS A POSSIBLE CONTRIBUTING FACTOR TO THE POST-OPERATIVE THERMAL BURN INJURIES EXPERIENCED BY THE 3 PATIENTS. ON 07/21/2015, AN ISI TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE. THE TFS VERIFIED THAT THE PATIENT SIDE CART (PSC) AND CANNULA MOUNTS PASSED ELECTRICAL SAFETY CHECKS. THE FSE ALSO VERIFIED THAT THE FOOT SWITCHES ON THE SURGEON SIDE CONSOLE (SSC) WERE WORKING PROPERLY. THE TFS VERIFIED THAT THE DA VINCI SYSTEM WAS OPERATING CORRECTLY AND SAFELY, AND WAS READY FOR USE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }