{ "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": "2955842-2013-03695", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130919", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20080507", "reprocessed_and_reused_flag": "", "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": "20130920", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "472129", "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": "0", "model_number": "IS1200", "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": "20250805", "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 SURGICAL SYSTEM, INSTMNT, ACCESS & ES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Muscle Spasm(s)", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20130821", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3358888", "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": "3931900", "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 SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2008 WITH A PRE-OPERATIVE DIAGNOSIS OF MARKEDLY LARGE UTERINE FIBROIDS WITH A 19CM UTERUS. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT DATED (B)(6) 2008, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. DUE TO THE LARGE SIZE OF THE PATIENT'S UTERUS, IT WAS MORCELLATED AND WAS REMOVED IN SMALL PIECES. THE OPERATIVE REPORT DOES NOT HAVE ANY INDICATION OF BOWEL OR BLADDER INJURY. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2008, THE PATIENT UNDERWENT A CT UROGRAM. THE FINDINGS SHOWED THAT THE PATIENT HAD A VESICOVAGINAL FISTULA WITH THE DEFECT IN THE BLADDER BASE APPROXIMATELY 13MM IN SIZE. THERE WAS NO EVIDENCE OF RENAL OR PROXIMAL URETERAL STONES AND THE PATIENT'S LUNG BASES WERE CLEAR. THE PATIENT'S KIDNEYS WERE NORMAL IN SIZE AND HOMOGENEOUSLY ENHANCING. THERE WAS NO EVIDENCE OF MASSES OR HYDRONEPHROSIS AND THE PATIENT HAD NO PELVIS ABNORMALITIES. DURING A ROUTINE FOLLOW-UP ON (B)(6) 2008 THE PATIENT'S FISTULA WAS FOUND TO BE 13MM AND THE PATIENT WAS STILL EXPERIENCING LEAKAGE AND HAVING SPASMS. PER THE PATIENT'S MEDICAL RECORDS, THE PATIENT'S CONDITION WAS TO BE RE-EVALUATED IN MID AUGUST. ON (B)(6) 2008 THE PATIENT UNDERWENT A FLUOROSCOPIC PROCEDURE. THE FINDINGS SHOWED THAT THE PATIENT'S BLADDER WAS SMALLER AND THE FISTULA APPEARED TO BE SMALLER, MEASURING 10MM. ON (B)(6) 2008, THE PATIENT UNDERWENT A CYSTOSCOPY WITH BILATERAL STENT PLACEMENT, FOLLOWED BY REPAIR OF THE VESICOVAGINAL FISTULA WITH OMENTUM MOBILIZATION AND GRAFTING, AND SUPRAPUBIC TUBE PLACEMENT. THE PATIENT TOLERATED THE PROCEDURE AND WAS SENT TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2008, THE PATIENT UNDERWENT A PELVIC CT SCAN. THE FINDINGS SHOWED THAT THERE WAS NO LEAKAGE INTO THE PATIENT'S RECTUM AND HER PELVIS WAS INTACT." }, { "mdr_text_key": "11170257", "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 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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SI SUPRACERVICAL HYSTERECTOMY THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS." } ], "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": "" } ] }