{ "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": "2955842-2013-04769", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20080624", "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": "560330", "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": "20250808", "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": "52 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440079", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "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": "3901812", "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 WHO UNDERWENT A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR SEVERE DYSPLASIA PROCEDURE ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE SUBSEQUENT FISTULA REPAIR PROCEDURES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE HYSTERECTOMY PROCEEDED IN THE STANDARD MANNER WITH THE TUBO-OVARIAN LIGAMENTS AND ROUND LIGAMENTS COAGULATED AND CUT THEN THE BLADDER FLAP CREATED. THE UTERINE ARTERIES WERE SKELETONIZED AND CUT. THE COLPOTOMY WAS MADE WITH THE AID OF KOH RING, AND THE LATERAL CERVICAL VAGINAL ATTACHMENTS WERE COAGULATED AND CUT STAYING CLOSE TO THE UTERUS. THE VAGINAL CUFF WAS CLOSED WITH RUNNING SUTURE AND LIGATURES. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2008 THE PATIENT PRESENTED WITH A HISTORY OF RECURRENT LEAKAGE OF URINE THROUGH HER VAGINA, AND UNDERWENT CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAMS AND VAGINOSCOPY. PYELOGRAMS SHOWED NO FILLING DEFECTS, BUT A 2-3 CM OPENING ON THE POSTERIOR BLADDER WALL WAS CONNECTED TO THE VAGINA. ON (B)(6) 2008 PATIENT UNDERWENT TRANSVAGINAL REPAIR OF THE VESICOVAGINAL FISTULA. FROM A VAGINAL INCISION, THE FISTULOUS TRACK WAS EXCISED, THE VAGINA REPAIRED, AND BLADDER WATERTIGHTNESS AND URETERAL FUNCTION CONFIRMED WITH IV INDIGO CARMINE AND DIRECT OBSERVATION OF EFFLUX UNDER CYSTOSCOPY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2009 PATIENT DEVELOPED RECURRENT VESICOVAGINAL FISTULA, A CYSTOURETHROSCOPY ON (B)(6) SHOWED A HEALED FISTULA SITE, AND NO VISIBLE FISTULA. THE PATIENT WAS REFERRED FOR A CYSTOGRAM. ON (B)(6) 2009 A CYSTOGRAM SHOWED FILLING OF EXTRAVESICULAR STRUCTURES DURING ATTEMPTED VOIDING WHICH WAS FELT COULD REPRESENT REFLUX, FISTULA OR VAGINAL FILLING. SUBSEQUENT WORKUP CONFIRMED A SMALL RECURRENT VESICOVAGINAL FISTULA. ON (B)(6) 2009 PATIENT UNDERWENT CYSTOSCOPY WITH FULGURATION OF VESICOVAGINAL FISTULA FOR RECURRENT VESICOVAGINAL FISTULA. A SMALL TRACT WAS NOTED IN THE SAME PLACE AS THE PREVIOUS FISTULA AND WAS CAUTERIZED WITH A BUGBEE ELECTRODE. POSTOPERATIVELY, HOWEVER, THE FISTULA PERSISTED. ON (B)(6) 2009 PATIENT UNDERWENT EXPLORATORY LAPAROTOMY FOR REPAIR OF VESICOVAGINAL FISTULA AND CREATION AND INSERTION OF AN OMENTAL FLAP FOR PERSISTENT RECURRENT VESICOVAGINAL FISTULA. THE ABDOMEN WAS ENTERED THROUGH A PFANNENSTIEL INCISION, AND THE BLADDER MOBILIZED OFF OF THE VAGINA WITH SHARP DISSECTION UNTIL THE FISTULOUS TRACT WAS IDENTIFIED. THE FISTULOUS TRACT WAS EXCISED AND THE BLADDER REPAIRED IN LAYERS, AND THE VAGINA REPAIRED IN LAYERS. THE OMENTUM WAS MOBILIZED OFF THE COLON WITH PRESERVED BLOOD SUPPLY AND WAS SUTURED TO THE VAGINA AND INTERPOSED BETWEEN THE VAGINA AND BLADDER A LEFT URETERAL STENT WAS PLACED BECAUSE OF THE PROXIMITY OF THE REPAIR TO THE URETERAL ORIFICE. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2009 THE PATIENT HAD A FOLLOW UP CYSTOSCOPY AND RETROGRADE PYELOGRAM WHICH WAS NEGATIVE FOR THE PRESENCE OF FISTULA AND SHOWED NORMAL CALIBER OF LEFT URETER. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF THIS PROCEDURE." }, { "mdr_text_key": "11098366", "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 PATIENT SUSTAINED A BLADDER INJURY AFTER UNDERGOING A DA VINCI HYSTERECTOMY SURGICAL 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": "" } ] }