{ "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": "2955842-2013-03535", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130913", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110428", "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": "20130913", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "462911", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130913", "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.P7", "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": "20250814", "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": "20130913", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "41 YR", "patient_sex": "", "patient_weight": "79", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fever", "Fistula", "Incontinence", "Inflammation", "Urinary Tract Infection", "Burning Sensation", "Hematuria", "Dysuria" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3347715", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "17150284", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION AND MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE WITH LYSIS OF ADHESIONS AND CYSTOSCOPY ON (B)(6) 2011. THE CYSTOSCOPY AND RIGHT RETROGRADE PYELOGRAM WAS PERFORMED FOR HYDRONEPHROSIS BEFORE THE DA VINCI SURGICAL PROCEDURE BEGAN. THE OPERATIVE REPORT INDICATED THAT THE PATIENT'S URETERAL ORIFICES APPEARED NORMAL. THE PATIENT'S PREOPERATIVE DIAGNOSIS WAS DYSMENORRHEA, PELVIC PAIN, AND OVARIAN CYST. THE PATIENT HAD A LONG HISTORY OF DYSMENORRHEA AND GASTROINTESTINAL ISSUES. THE OPERATIVE REPORT STATED THAT THE PATIENT HAD A NORMAL-APPEARING LEFT OVARY, SURGICALLY ABSENT RIGHT OVARY, RIGHT HYDRONEPHROSIS AND HISTORY OF RIGHT OVARIAN CYST. THERE WAS ALSO PELVIC SCARIFICATION DUE IN PART TO SIGNIFICANT ENDOMETRIOSIS AND NORMAL OVARY WITH A SMALL CYST. NO COMPLICATIONS WERE NOTED FOR BOTH PROCEDURES. THE PATIENT WAS DISCHARGED HOME 2 DAYS AFTER THE SURGERY ON (B)(6) 2011. APPROXIMATELY, 1 WEEK AFTER THE PROCEDURE ((B)(6) 2011), SHE CONTACTED THE DOCTOR AND REPORTED BURNING WITH URINATION AND LOW GRADE TEMPERATURE. SHE WAS PRESCRIBED CIPRO. ON (B)(6) 2011, THE PATIENT HAD HER FOLLOWUP VISIT WITH THE SURGEON. SHE WAS COMPLAINING OF LEAKING EITHER VAGINAL FLUID OR URINE. ON (B)(6) 2011 SHE VISITED THE SURGEON WHO PERFORMED THE CYSTOSCOPY. THE RECORDS INDICATED THAT THE PATIENT HAD BEEN HAVING RECURRENT EPISODES OF SPONTANEOUS URINARY LEAKAGE. A CYSTOSCOPY WAS PERFORMED AND A DEFECT WAS NOTED IN THE MIDLINE OF THE BLADDER JUST ABOVE THE TRIGONE CONSISTENT WITH A VESICOVAGINAL FISTULA. THE BLADDER WAS UNREMARKABLE WITH MINIMAL INFLAMMATION. A FOLEY CATHETER WAS INSERTED FOR 2 WEEKS AND A REPEAT CYSTOSCOPY WOULD BE REPEATED. ON (B)(6) 2011, THE PATIENT RETURNED FOR A FOLLOWUP EVALUATION FOR THE VESICOVAGINAL FISTULA. THE PATIENT REPORTEDLY CONTINUED TO LEAK SIGNIFICANT AMOUNTS OF URINE THROUGH THE VAGINA. THE PATIENT DEVELOPED AN EPISODE OF HEMATURIA, DYSURIA, AND WAS SEEN AT HER LOCAL EMERGENCY ROOM ON AN UNSPECIFIED DATE WHERE SHE WAS TREATED FOR POSSIBLE URINARY TRACT INFECTION. THE CYSTOGRAM REVEALED DEFINITE LEAKAGE OF CONTRAST INTO THE APEX OF HER VAGINA. THE PELVIC EXAMINATION REVEALED AN APPARENT FISTULA AT THE SITE OF THE VAGINAL CUFF. A CT SCAN OF THE ABDOMEN AND PELVIS PERFORMED ON (B)(6) 2011 INDICATED THAT THE UTERUS APPEARED SMALL, SUGGESTING SURGERY. THE LEFT ADNEXAL REGION LIKELY HAS AN OVARIAN CYST. THERE WAS NO GAS IN THE BLADDER TO SUPPLY EVIDENCE OF A FISTULA AND THERE WAS NO ABNORMAL TISSUE THICKENING SEEN BETWEEN THE VAGINAL REGION AND URINARY BLADDER. THERE WERE NO OTHER MEDICAL RECORDS TO INDICATE IF THE PATIENT UNDERWENT A REPAIR FOR THE VESICOVAGINAL FISTULA. PATIENT'S CURRENT CONDITION WAS NOT PROVIDED." }, { "mdr_text_key": "17362352", "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. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2011 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. 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": "" } ] }