{ "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": "2955842-2013-04878", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20120416", "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": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562329", "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": "", "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": "20250811", "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": "47 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": "3442976", "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": "18858076", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR MENOMETRORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES A HANDWRITTEN LIMITED HISTORY AND PHYSICAL RECORD FROM (B)(6) 2012 AND SEVERAL RADIOLOGIC REPORTS. ACCORDING TO THE MEDICAL RECORDS, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AFTER INTRAVAGINAL PLACEMENT OF THE ROOMY UTERINE MANIPULATOR, A PNEUMOPERITONEUM WAS CREATED USING A VERESS NEEDLE THROUGH THE UMBILICUS AND PORTS WERE PLACED UNDER DIRECT VISUALIZATION. THE UTERO-OVARIAN AND ROUND LIGAMENTS WERE CAUTERIZED WITH THE PK DEVICE AND TRANSECTED WITH MONOPOLAR SCISSORS. THE BLADDER WAS SHARPLY TAKEN OF THE UTERUS AND THE BLADDER FLAP CREATED WHILE THE VESSELS AND TISSUE WAS CAUTERIZED AND TRANSECTED IN A SIMILAR FASHION. SOME BLEEDING WAS NOTED ON THE LEFT SIDE FROM A RESIDUAL VESSEL COMING OF THE UTERINE ARTERY. AFTER COLPOTOMY, THE UTERUS WAS REMOVED THROUGH THE CUFF AND THE COLPOTOMY CLOSED USING A V-CARE STICH. CLOSE TO THE END OF THE CLOSURE LINE THE V-CARE STITCH HAD POPPED AND 2 ADDITIONAL INTERRUPTED STITCHES OF VICRYL 0 WERE PLACED TO CLOSE THE REMAINDER OF THE CUFF. SURGICEL WAS PLACED ACROSS THE CUFF AND ARISTA USED OVER THE PEDICLES. THE PATIENT WAS DISCHARGED HOME AFTER UNCOMPLICATED RECOVERY ON POSTOPERATIVE DAY 1. IT WAS NOTED THAT 3 TO 4 WEEKS POSTOPERATIVELY, THE PATIENT HAD SYMPTOMS AND SIGNS OF A URINARY FISTULA. ON (B)(6) 2012, A CYSTOURETHROSCOPY, RETROGRADE PYELOGRAM, PLACEMENT OF RIGHT DOUBLE-J URETERAL STENT, PLACEMENT OF SUPRAPUBIC CYSTOSTOMY TUBE, AND ABDOMINAL TRANSVESICAL VESICOVAGINAL FISTULA REPAIR WERE PERFORMED. DURING CYSTOSCOPY, THE FISTULA WAS VISUALIZED ABOVE THE RIGHT URETERAL ORIFICE IN THE POSTERIOR ASPECT OF THE BLADDER. THROUGH AN INCISION ACROSS THE LOWER ABDOMEN THE BLADDER WAS VENTRALLY OPENED. THE FISTULA WAS IDENTIFIED AND SURROUNDING TISSUE DEBRIDED, ALSO A SMALL STITCH FROM PRIOR SURGERY IN THIS AREA WAS REMOVED. THE BLADDER WAS CLOSED OVER THE FISTULA SITE POSTERIORLY, AS WELL AS THE ANTERIOR ACCESS. THE PATIENT TOLERATED THE PROCEDURE WELL AND HAD AN UNEVENTFUL POSTOPERATIVE COURSE UNTIL SHE WAS DISCHARGED HOME ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "19212073", "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 MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. 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 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": "" } ] }