{ "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": "2955842-2013-03151", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101007", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "409424", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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, A60.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": [ "Fluid/Blood Leak" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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 SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Fistula", "Incontinence", "Inflammation", "Perforation", "Abnormal Vaginal Discharge", "Injury", "Abdominal Distention", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305592", "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": "3587090", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2010 FOR TREATMENT OF CHRONIC PELVIC PAIN AND ABNORMAL UTERINE BLEEDING. THE PATIENT REPORTEDLY HAD A SMALL PERFORATION OF THE BLADDER DURING THE PROCEDURE, WHICH THE SURGEON REPAIRED. THE SURGEON REPAIRED THE BLADDER INJURY BUT ALSO REQUESTED AN INTRAOPERATIVE CONSULT FROM ANOTHER SURGEON TO PERFORM A CYSTOSCOPY TO ENSURE THERE ARE NO OTHER ABNORMALITIES OR INJURIES AND TO ASSESS DRAINAGE FROM THE URETERAL ORIFICES. THE BLADDER WAS FOUND TO BE FULLY DISTENDED AND THERE WAS NO EVIDENCE OF SIGNIFICANT EXTRAVASATION OF URINE OR LEAKAGE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION. THE OPERATIVE REPORTS DID NOT CONTAIN ANY REPORT OF A MALFUNCTION OF THE DA VINCI SI SYSTEM, INSTRUMENTS, OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE BLADDER INJURY. TEN DAYS AFTER THE SURGICAL PROCEDURE ((B)(6) 2010), THE PATIENT HAD HER FOLLOWUP APPOINTMENT TO REMOVE THE FOLEY CATHETER. DURING THIS VISIT, SHE HAD COMPLAINTS OF A MALODOROUS VAGINAL DISCHARGE. THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE THERE WAS A CONCERN THAT URINE WAS LEAKING FROM THE FOLEY CATHETER. THE SURGEON SUSPECTED A COMMUNICATION BETWEEN THE VAGINA AND THE BLADDER. THE FOLLOWING DAY ((B)(6) 2010), A PELVIC EXAM WAS PERFORMED. THERE WAS SOME EVIDENCE OF WOUND DEHISCENCE AT THE TOP OF THE VAGINAL CUFF AND THERE WAS PROBABLY URINE WITHIN THE VAGINA. A CT UROGRAM AND CT PELVIS WERE PERFORMED ON (B)(6) 2010, WHICH CONFIRMED A VESICOVAGINAL FISTULA WITH INFLAMMATORY CHANGES AROUND THE URINARY BLADDER AND VAGINA, AND SIGMOID DIVERTICULOSIS. NO DISCHARGE SUMMARY IS AVAILABLE FOR ANY ADDITIONAL INFORMATION. ON (B)(6) 2010, THE PATIENT WAS SEEN BY THE UROLOGIST WHO HAD PERFORMED THE CYSTOSCOPY ON (B)(6) 2010. THE PATIENT WAS DISCHARGED WITH A FOLEY CATHETER AND RETURNED BACK ON (B)(6) 2010. AT THIS TIME A REPEATED CYSTOSCOPY DEMONSTRATED A PERSISTENT DEFECT AT THE VAGINAL CUFF AND FISTULA. THE CYSTOSCOPY DEMONSTRATED FOREIGN BODIES IN THE BLADDER CONSISTENT WITH SUTURE MATERIAL. TWO PIECES WERE REMOVED FROM THE FISTULA TRACK; HOWEVER, THE UROLOGIST RECOMMENDED ANOTHER CYSTOSCOPY UNDER ANESTHESIA. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT CONTINUED TO BE TREATED FROM (B)(6) 2010 THROUGH (B)(6) 2011 FOR CYSTOGRAMS AND VESICOVAGINAL FISTULA REPAIRS. THE PATIENT'S CURRENT CONDITION WAS NOT PROVIDED. A RETROGRADE EXAM PERFORMED ON (B)(6) 2011 SHOWED NO EVIDENCE OF FISTULA, HOWEVER, ON (B)(6) 2011 THE PATIENT REPORTED INCONTINENCE. THE VAGINAL EXAM DID NOT SHOW ANY EVIDENCE OF FISTULA. KEGEL EXERCISES WAS RECOMMENDED AND THE PATIENT WAS REQUIRED TO REPORT BACK IN 6 MONTHS. NO ADDITIONAL MEDICAL RECORDS RELATED TO THE PATIENTS CURRENT MEDICAL CONDITION HAS BEEN PROVIDED." }, { "mdr_text_key": "11018242", "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. ISI MADE AN ATTEMPT TO CONTACT THE SITE TO OBTAIN MORE INFORMATION ABOUT THE REPORTED EVENT BUT HAS NOT RECEIVED ANY ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. BASED ON THE PROVIDED INFORMATION, THERE WAS NO EVIDENCE THAT THE DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES MALFUNCTIONED. HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI 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": "" } ] }