{ "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": "2955842-2013-04911", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20030218", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "563337", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": "20131101", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "146 YR", "patient_sex": "", "patient_weight": "69", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fatigue", "Fistula", "Hemorrhage/Blood Loss/Bleeding", "Incontinence", "Necrosis", "Internal Organ Perforation", "Weight Changes" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444112", "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": "3788681", "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 SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) FOR FIBROID UTERUS ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL ON (B)(6) 2013. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION (INCIDENTAL CYSTOTOMY). AFTER INSERTION OF THE V-CARE UTERINE MANIPULATOR AND CREATION OF A PNEUMOPERITONEUM WITH THE VERESS NEEDLE , 4 ADDITIONAL PORTS WERE INSERTED AND THE ROBOT DOCKED. INSPECTION OF THE PELVIS REVEALED SEVERE OMENTAL AND SMALL BOWEL ADHESIONS. EXTENSIVE ADHESIOLYSIS WAS PERFORMED ANTERIORLY BY THE BLADDER AS WELL AS SEPARATING THE SMALL BOWEL FROM THE POSTERIOR FUNDUS UTERI. LATERAL LIGAMENTS WERE CAUTERIZED AND CUT BILATERALLY DOWNWARDS. THE BLADDER FLAP WAS CREATED USING SHARP AND BLUNT DISSECTION. THEN A POSTERIOR COLPOTOMY WAS PERFORMED FOLLOWED BY A CIRCUMFERENTIAL INCISION AFTER CAUTERIZATION. THE SPECIMEN WAS THEN REMOVED THROUGH THE VAGINA. AT THIS TIME, THE FOLEY CATHETER BULB WAS NOTED DELINEATING AN INCIDENTAL CYSTOTOMY. FOLLOWING THIS, THE BLADDER WAS REPAIRED USING A V-LOC SUTURE. THE VAGINAL CUFF WAS THEN CLOSED, ALSO USING THE V-LOC SUTURE. THE FOLEY CATHETER WAS REMOVED 9 DAYS POSTOPERATIVELY AND THE PATIENT DID WELL UNTIL (B)(6) 2013 WHEN SHE BEGAN HAVING A URINE LEAK OUT OF THE VAGINA. ON (B)(6) 2013 THE PATIENT PRESENTED WITH FATIGUE, WEIGHT LOSS AND INCONTINENCE FOR URINE WITH CONSTANT LEAKAGE OF LARGE FLUID AMOUNTS. ON (B)(6) 2013 THE PATIENT UNDERWENT A VESICOVAGINAL FISTULA REPAIR WITH OMENTAL FLAP AND BILATERAL URETERAL REIMPLANTS WITH BILATERAL URETERAL DOUBLE-J STENTS FOR A VESICOVAGINAL FISTULA AND INCONTINENCE POST-HYSTERECTOMY. SURGERY REVEALED A LARGE FISTULOUS HOLE WITH NECROTIC EDGES IN THE POSTERIOR WALL OF THE BLADDER MEASURING APPROXIMATELY 2 CM IN DIAMETER. AT THE LEVEL OF THE FISTULA, THE URETER WAS NOTED TO BE ENTERING THIS FISTULOUS TRACT TO THE VAGINA. BECAUSE OF THE EXTENSIVENESS OF THE POSTOPERATIVE ADHESIONS AND THE TRANSECTION OF THE LEFT URETER, BOTH URETERS WERE PURPOSEFULLY TRANSECTED AT THEIR MOST DISTAL POINT, WHERE THEY APPEARED HEALTHY AND VIABLE AND WERE LATER ON REIMPLANTED INTO THE BLADDER. POSTOPERATIVELY SHE REQUIRED 2 UNITS OF BLOOD AND SHE HAD AN EXPECTED ILEUS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013. THE PATIENT UNDERWENT A CYSTOSCOPY WITH STENT REMOVAL ON (B)(6) 2013." }, { "mdr_text_key": "11375231", "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 FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI 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": "" } ] }