{ "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": "2955842-2013-03178", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20121031", "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", "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "415066", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI S 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": "IS 2000 A51.P8", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20130823", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "34 YR", "patient_sex": "", "patient_weight": "70", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Adhesion(s)", "Hemorrhage/Blood Loss/Bleeding", "Vomiting", "Cramp(s)", "Discharge" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305944", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "3835477", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON 07/25/2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY AND CYSTOSCOPY PROCEDURE ON (B)(6) 2012 DUE TO A HISTORY OF DYSFUNCTIONAL UTERINE BLEEDING, UNRESPONSIVE TO MEDICAL MANAGEMENT. ONE DAY PRIOR TO THE PROCEDURE ((B)(6) 2012), SHE WAS DIAGNOSED WITH BACTERIAL VAGINITIS AND PLACED ON ANTIBIOTICS. ACCORDING TO THE OPERATIVE REPORT, THERE WERE NO REPORTS OF COMPLICATIONS DURING THE SURGICAL PROCEDURE. A CYSTOSCOPY WAS PERFORMED AND INDIGO CARMINE WAS CONFIRMED TO COME OUT BOTH URETERAL ORIFICES. THE SURGEON NOTED THAT THE PATIENT HAD A NORMAL PELVIS, NORMAL UPPER ABDOMEN AND HAD NORMAL FLOW INTO THE BLADDER OF URINE AFTER THE CASE FROM THE URETERS. THE BLADDER REPORTEDLY HAD GOOD INTEGRITY WITH NO LEAKS. THE PATIENT WAS TAKEN INTO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED ON (B)(6) 2012, SHE WAS AFEBRILE, VOIDING AND TOLERATING A REGULAR DIET. ON (B)(6) 2013, THE PATIENT WENT TO HER DOCTOR'S OFFICE WITH COMPLAINTS OF RECURRENT VAGINAL DISCHARGE AND POST COITAL BLEEDING. ON (B)(6) 2013, THE VAGINAL CUFF WAS NOTED TO BE NOT COMPLETELY HEALED BUT IT WAS INTACT. LATER THE SAME DAY, SHE WENT TO THE EMERGENCY ROOM (ER) FOR VAGINAL BLEEDING AND ABDOMINAL CRAMPING. A CT PELVIC SCAN WAS PERFORMED, WHICH REVEALED THAT THE WALLS OF THE VAGINAL CUFF WERE DIFFUSELY MILDLY THICKENED AND THERE WAS A SMALL AMOUNT OF FREE FLUID WITHIN THE POSTERIOR CUL DE SAC. THE PATIENT WAS TREATED WITH MEDICATIONS AND WAS ADVISED TO FOLLOWUP WITH HER GYNECOLOGIST. THE PATIENT WAS SENT HOME THE SAME DAY. ON (B)(6) 2013, THE PATIENT VISITED HER DOCTOR FOR ACUTE ONSET OF PELVIC PAIN AND WAS PRESCRIBED MEDICATIONS FOR A VAGINAL CUFF CELLULITIS. THE PATIENT REPORTEDLY DID NOT HAVE ANY RECURRENT PROBLEMS UNTIL APPROXIMATELY 4.5 MONTHS AFTER THE DA VINCI PROCEDURE. ON (B)(6) 2013, THE PATIENT WENT TO THE ER WITH COMPLAINTS OF ABDOMINAL PAIN, VAGINAL BLEEDING, AND VOMITING. A CT SCAN OF THE ABDOMEN AND PELVIS SHOWED A LARGE AMOUNT OF FREE AIR IN THE BELLY, AND A SUSPECTED VAGINAL AND/OR RECTAL PERITONEAL FISTULA. SHE WAS TAKEN TO THE OPERATING ROOM FOR A SUSPECTED VAGINAL CUFF DEHISCENCE. A DIAGNOSTIC LAPAROSCOPY WAS PERFORMED AND THE VAGINAL CUFF WAS RESECTED AND CLOSED ALONG WITH LYSIS OF ADHESIONS OF THE DESCENDING COLON. SHE WAS DISCHARGED HOME ON (B)(6) 2013 IN STABLE CONDITION. FOLLOW UP IN THE DOCTOR'S OFFICE ON (B)(6) 2013 INTERNAL FOR HEMORRHOIDS ONLY AND HER VAGINAL CUFF WAS NOTED TO BE INTACT. THE PATIENT WAS PRESCRIBED A TOPICAL ANTI-INFLAMMATORY AND ANTIPRURITIC MEDICATION AND WAS ASKED TO RETURN TO THE CLINIC AS NEEDED. NO ADDITIONAL INFORMATION SINCE THE (B)(6) 2013 VISIT IS AVAILABLE." }, { "mdr_text_key": "11022067", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE OPERATIVE REPORTS DO NOT HAVE ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL HYSTERECTOMY PROCEDURE." } ], "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": "" } ] }