{ "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": "2955842-2013-04924", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100409", "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": "562278", "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": [ "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": "20250816", "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": "41 YR", "patient_sex": "", "patient_weight": "96", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Hemorrhage/Blood Loss/Bleeding", "Nausea", "Pain", "Pneumonia", "Thrombus", "Abnormal Vaginal Discharge", "Vomiting", "Organ Dehiscence" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444156", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "3901516", "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 TOTAL HYSTERECTOMY FOR REFRACTORY MENORRHAGIA ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS. IN ADDITION, A PATHOLOGY REPORT WAS PROVIDED. 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. THE PROCEDURE WAS UNEVENTFUL - OVARIES WERE LEFT IN PLACE PER PATIENT'S WISHES. THE UTERUS WEIGHED 134 GRAMS. SHE WAS MOVED TO THE POST-ANESTHESIA CARE UNIT IN GOOD CONDITION. ESTIMATED BLOOD LOSS WAS 450ML. SHE WAS DISCHARGED HOME ON (B)(6) 2010 FOR A TOTAL STAY OF ONE DAY. ON (B)(6) 2010 THE PATIENT PRESENTED WITH NAUSEA, VOMITING AND ABDOMINAL PAIN. SHE REPORTED A BROWNISH RED VAGINAL DISCHARGE. A DIAGNOSIS OF POSTOP ILEUS WAS MADE. A CT SCAN WAS CONDUCTED ON (B)(6) 2010 AND NOTED ATELECTASIS IN BOTH LOWER LUNG FIELDS. A PULMONARY THROMBOEMBOLISM WAS NOT NOTED, BUT POSSIBLE EARLY INFILTRATES WERE NOTICED IN THE RIGHT BASE COULD BE EARLY PNEUMONIA. KIDNEYS WERE NOTED AS NORMAL. A LATER PYELOGRAM NOTED LEFT HYDRONEPHROSIS AND A DILATED LEFT URETER. ON (B)(6) 2010 A CYSTOSCOPY AND LEFT RETROGRADE PYELOGRAM WERE PERFORMED IN ADDITION TO URETEROSCOPY AND THE INSERTION OF A URETERAL STENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. SHE WAS DISCHARGED HOME ON (B)(6) 2010 FOR A TOTAL HOSPITAL STAY OF 8 DAYS. ON (B)(6) 2010 SHE PRESENTED WITH VAGINAL BLEEDING, AND ABDOMINAL AND LEFT LOWER BACK PAIN. UPON VAGINAL EXAM THERE WAS OBVIOUS BLOOD CLOTS AND BLOOD AND A POSSIBLE DEFECT ON THE VAGINAL CUFF WAS PALPATED. A SUBSEQUENT DIAGNOSTIC LAPAROSCOPIC EXAM NOTED 100ML OF CLOTTED BLOOD IN THE VAGINA AND VAGINAL CUFF DEHISCENCE. THE VAGINAL CUFF WAS REPAIRED WITHOUT COMPLICATION AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. SHE WAS DISCHARGED ON 04/28/10. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE" }, { "mdr_text_key": "11252203", "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": "" } ] }