{ "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": "2955842-2013-03677", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130919", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120221", "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": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130919", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "473383", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130919", "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 A6.0P8", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20130919", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRMNTS, ACCESSORIES & ESU." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "45 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Incontinence", "Internal Organ Perforation" ] } ], "distributor_city": "", "date_report": "20130821", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3357807", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130821", "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": "3746100", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY, A LEFT SALPINGECTOMY, CYSTOTOMY REPAIR AND CYSTOSCOPY. THE PATIENT HAD A PRE-DIAGNOSIS OF MENOMETRORRHAGIA, FIBROID UTERUS AND A HISTORY OF ANEMIA. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT DATED (B)(4) 2012, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED; HOWEVER, THE PATIENT SUSTAINED A SMALL CYSTOMY DURING THE SURGICAL PROCEDURE. REPORTEDLY, AFTER THE SURGEON HAD DISSECTED THE BLADDER FREE FROM THE PATIENT'S CERVIX A SMALL CYSTOTOMY WAS IDENTIFIED APPROXIMATELY 5MM IN SIZE. THE DEFECT TO THE PATIENT'S BLADDER WAS REPAIRED WITH SUTURES. AFTER CLOSURE OF THE PATIENT'S VAGINAL CUFF WAS COMPLETED, THE SURGICAL AREA WAS IRRIGATED AND GOOD HEMOSTASIS WAS NOTED. A CYSTOSCOPY WAS THEN PERFORMED AND THE PATIENT WAS ADMINISTERED INDIGO CARMINE. A GOOD EXTRUSION OF URINE FROM BOTH URETERAL ORIFICES WAS NOTED. THE BLADDER REPAIR WAS ALSO VISUALIZED AND NOTED TO BE INTACT. THE PATIENT WAS AWAKENED IN STABLE CONDITION FOLLOWING THE SURGICAL PROCEDURE. POST-OPERATIVELY THE PATIENT DID WELL AND SHE WAS ABLE TO AMBULATE, URINATE AND WAS AFEBRILE. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. DURING A POST-OP FOLLOW-UP ON (B)(6) 2012, IT WAS DISCOVERED THAT THE PATIENT HAD A SMALL FISTULA BETWEEN THE BLADDER AND VAGINA. PER THE INFORMATION INDICATED IN THE PATIENT'S MEDICAL RECORDS, AT THAT TIME, THE PHYSICIAN MADE THE DECISION WAIT FOR THE FISTULA TO MATURE BEFORE TREATMENT WITH CLOSURE OF THE FISTULA. THE PATIENT WAS FOLLOWED UP EVERY FEW WEEKS TO CHECK ON THE STATUS OF THE FISTULA TRACK. ON (B)(6) 2012 THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR HER VESICOVAGINAL FISTULA. THE AFFECTED AREA WAS REPAIRED WITH SUTURES. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO COMPLICATIONS EXPERIENCED BY THE PATIENT. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ACCORDING TO THE PATIENT MEDICAL RECORDS, DURING TWO SUBSEQUENT POST-SURGICAL FOLLOW UP VISITS ON (B)(6) 2012, THE PATIENT WAS FOUND TO BE RECOVERY WELL; HOWEVER, ON (B)(6) 2012, DURING A ROUTINE VISIT, THE PATIENT COMPLAINED OF INCONTINENCE, WITH NO SIGNS OF DYSURIA AND NO GROSS HEMATURIA. PER THE MEDICAL RECORDS, THE SURGEON DISCUSSED WITH THE PATIENT THAT HER INCONTINENCE COULD BE DUE TO RECURRENCE OF FISTULA OR STRESS INCONTINENCE AS WAS ASKED TO COME BACK FOR AN EVALUATION AT A LATER DATE. ON (B)(6) 2012, DURING A ROUTINE FOLLOW-UP EXAMINATION, THE PATIENT COMPLAINING OF SEVERE INCONTINENCE, REQUIRED PADS 4 TIMES DAILY, HAD THROBBING PAINS WHEN URINATING FOR APPROXIMATELY 6 WEEKS. PER THE INFORMATION PROVIDED, THE PATIENT FELT THAT SHE HAD A FISTULA AND SEVERE INCONTINENCE AND THAT IT WAS GETTING WORSE. ON (B)(6) 2012, THE PATIENT UNDERWENT CYSTOSCOPY AND VAGINOSCOPY PROCEDURES. DURING THE EXAMINATION, THE PHYSICIAN WAS UNABLE TO FIND A FISTULOUS TRACT. PER THE OP NOTES, THE OPERATING SURGEON RULED OUT A POSSIBILITY OF RECURRENCE OF FISTULA OR STRESS INCONTINENCE AND DIAGNOSED THE PATIENT'S CONDITION AS AN OVERACTIVE BLADDER. NO SUBSEQUENT MEDICAL RECORDS HAVE BEEN PROVIDED TO ISI." }, { "mdr_text_key": "11083842", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF POST SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED POST-SURGICAL COMPLICATIONS FOLLOWING A DA VINCI SI HYSTERECTOMY AND LEFT SALPINGECTOMY, CYSTOTOMY REPAIR AND CYSTOSCOPY." } ], "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": "" } ] }