{ "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": "2955842-2013-04759", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100309", "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": "20131031", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "560457", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "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": "20250825", "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": "20131031", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES&ES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Incontinence" ] } ], "distributor_city": "", "date_report": "20131001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3439844", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131001", "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": "21006022", "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 THE POST- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT, A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED POST -SURGICAL COMPLICATIONS." }, { "mdr_text_key": "20639223", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT HAD UNDERWENT A DA VINCI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PLICATION OF THE UTEROSACRAL LIGAMENT AND LYSIS OF ADHESIONS FOR THE INDICATION OF FIBROID UTERUS AND MENOMETRORRHAGIA PROCEDURE ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY AND FOLLOW UP SURGERY AND OFFICE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THE PATIENT'S UTERUS WAS NOTED TO BE LARGE AND DEFORMED WITH SEVERAL FIBROIDS, AND AN ADHESION OF THE LEFT OVARY TO THE PELVIC SIDEWALL WITH A CLEAR FLUID CYST. THE STANDARD PROCEDURE WAS PERFORMED WITH ISOLATION, CAUTERIZATION AND CUTTING OF THE LATERAL LIGAMENTS AND UTERINE ARTERIES BILATERALLY. THE RIGHT SIDE WAS NOTED TO BE ADHERED TO THE RIGHT ABDOMINAL WALL MAKING ACCESS TO THE IP LIGAMENT DIFFICULT. THE VAGINAL INCISION WAS MADE AROUND A VCARE AND THE UTERUS DELIVERED VAGINALLY. THE VAGINAL CUFF WAS CLOSED WITH 0 VICRYL, THE UTEROSACRAL LIGAMENT PLICATED. NO COMPLICATIONS WERE NOTED DURING THE SURGERY. ON (B)(6), THE PATIENT PRESENTED WITH A HISTORY OF POSTOPERATIVE URINARY INCONTINENCE. ON (B)(6), SHE WAS DIAGNOSED WITH A VESICOVAGINAL FISTULA SECONDARY TO CT WORKUP AND CYSTOGRAM (RECORDS NOT AVAILABLE) ON (B)(6) 2010, PATIENT UNDERWENT CYSTOSCOPY AND TRANSVAGINAL REPAIR OF VESICOVAGINAL FISTULA. THE FISTULA WAS SHARPLY DISSECTED, REPAIRED ON THE VAGINAL WALL WITH NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) WITH FOLEY CATHETER. ON (B)(6) 2012, THE PATIENT PRESENTED WITH RECURRENT URINARY INCONTINENCE AND WAS REFERRED FOR CYSTOTOMY AND REPAIR ON (B)(6) 2010, PATIENT UNDERWENT DAVINCI VESICOVAGINAL FISTULA REPAIR TO TREAT PERSISTENT VESICOVAGINAL FISTULA. LYSIS OF ADHESIONS WAS PERFORMED, THE EXCISION OF THE FISTULA TRACT AND PRIMARY REPAIR OF THE BLADDER AND VAGINAL WALL WITH INTERPOSITION OF AN OMENTAL FLAP. THE BLADDER WAS HYDRODISTENDED WITH NO EVIDENCE OF LEAK. NO INTRAOPERATIVE COMPLICATIONS. PATIENT WAS DISCHARGED HOME ON (B)(6). ON (B)(6) 2010, PATIENT PRESENTED WITH RIGHT FLANK PAIN AND HEMATURIA SECONDARY TO SUPRAPUBIC TUBE. ON (B)(6) 2010, PATIENT PRESENTED WITH COMPLETE RESOLUTION OF INCONTINENCE." } ], "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": "" } ] }