{ "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": "Death", "report_number": "2955842-2015-00941", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20150626", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131212", "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", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150626", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "415426", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150626", "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", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20150626", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "138", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Arrhythmia", "Bradycardia", "Cardiac Arrest", "Death", "Diarrhea", "Hyperglycemia", "Ischemia", "Myocardial Infarction", "Nausea", "Respiratory Distress", "Scar Tissue", "Swelling", "Tachycardia", "Vomiting", "Weakness", "Hypovolemia", "Loss of consciousness", "Cancer" ] } ], "distributor_city": "", "date_report": "20150529", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4871159", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150529", "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": "15311555", "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-ASSISTED TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, AND PARA-AORTIC LYMPHADENECTOMY FOR OVARIAN CANCER ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. PER THE SURGICAL NOTE, THE ABDOMEN WAS FIRST ENTERED BY SCOPE AT THE LEVEL OF THE LEFT UPPER QUADRANT RIGHT BELOW THE RIB CAGE IN ORDER TO OBSERVE IF THERE WERE ADHESIONS FROM THE PREVIOUS CHOLECYSTECTOMY IN THE UPPER ABDOMEN CLOSE TO THE UMBILICUS, BECAUSE SHE PRESENTED A LARGE SCAR. ADHESIONS WERE SEEN AND LYSED BY ENDO SHEARS AND MONOPOLAR CURRENT OVER A 10-15 MINUTE TIME BEFORE THE CAMERA COULD BE INSERTED. SURGICAL FINDINGS ALSO NOTED ENLARGED LYMPH NODES SUSPICIOUS FOR MALIGNANCY AND AN ENLARGED FIBROID UTERUS THAT REQUIRED MORCELLATION FOR REMOVAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. SHE WAS INSTRUCTED TO FOLLOW UP WITH THE SURGEON IN 7-10 DAYS. AROUND (B)(6) 2013, THE PATIENT DEVELOPED NAUSEA, VOMITING, DIARRHEA, WEAKNESS. THE SYMPTOMS WORSENED AND EMS WAS CALLED (B)(6)2013. EMS FOUND THE PATIENT ALERT AND ORIENTED AND NOT IN RESPIRATORY DISTRESS. AN EKG SHOWED SINUS TACHYCARDIA. HER OXYGEN SATURATION WAS 98% ON ROOM AIR AND HER BLOOD GLUCOSE WAS 237. IN ROUTE TO THE HOSPITAL, THE PATIENT BEGAN VOMITING PROFUSELY AND CONTINUOUSLY. THE PATIENT THEN BECAME BRADYCARDIC AND UNRESPONSIVE AND WENT INTO ASYSTOLE. A CARDIAC DEFIBRILLATOR WAS USED TWO TIMES FOR VENTRICULAR FIBRILLATION. THE PATIENT ARRIVED IN THE ER UNRESPONSIVE, IN RESPIRATORY ARREST, AND WITH ASYSTOLE. RESUSCITATION EFFORTS FAILED AND THE PATIENT EXPIRED. ON (B)(6) /2013, AN AUTOPSY WAS PERFORMED. PER THE FINAL REPORT, THE ANATOMIC CAUSE OF DEATH WAS CARDIAC ARREST FOLLOWING SMALL BOWEL OBSTRUCTION. PER THE AUTOPSY REPORT, THE MOST SIGNIFICANT PATHOLOGIC FINDING WAS INCARCERATION OF SMALL BOWEL BENEATH A 1 CM SURGICAL SCAR IN THE LEFT UPPER QUADRANT. ABDOMINAL OR PELVIC SURGERY IS THE MOST IMPORTANT RISK FACTOR FOR INTESTINAL OBSTRUCTION. THE ABDOMINAL HYSTERECTOMY [THE PATIENT'S NAME] UNDERWENT 2 WEEKS PRIOR TO HER DEATH IS UNLIKELY TO ACCOUNT FOR THIS PATHOLOGIC FINDING, HOWEVER AS THE ADHESED PORTION OF THE SMALL INTESTINE WAS FIRMLY AND DEEPLY EMBEDDED WITHIN THE ABDOMINAL WALL WITHOUT HEMORRHAGE OR HYPEREMIA, GRANULATION TISSUE, OR OTHER SIGNS OF A MORE RECENT SURGICAL ALTERATION. THE APPEARANCE OF THE OVERLYING SMALL SCAR SUGGESTS IT SERVED AS TROCAR SITE, PERHAPS DURING A LAPAROSCOPIC CHOLECYSTECTOMY OR APPENDECTOMY. ALSO, IT IS NOTED, IN OUR VIEW, THE LIKELY SEQUENCE OF EVENTS THAT LED TO [THE PATIENT'S NAME] DEATH WERE: DEVELOPMENT OF BOWEL ADHESION AND OBSTRUCTION BENEATH A PREVIOUS SURGICAL SITE, FOLLOWED BY PROGRESSIVE PROXIMAL DISTENSION THAT RESULTED IN ISCHEMIA AND POTASSIUM LEAKAGE, FOLLOWED BY HYPOVOLEMIA AND REDUCED CARDIAC PERFUSION. MYOCARDIAL INFARCTION, ARRHYTHMIA, OR BOTH LIKELY RESULTED: MYOCARDIAL INFARCTION FROM THE REDUCED CARDIAC PERFUSION, AND ARRHYTHMIA FROM THE COMBINATION OF MYOCYTE HYPOXIA AND ACUTE HYPERKALEMIA, AN ESTABLISHED CAUSE OF BUNDLE BRANCH BLOCK AND SLOWED ATRIOVENTRICULAR CONDUCTION (3). IN ADDITION, THE FINAL REPORT STATED, THESE MULTIPLE INSULTS RESULTED IN ASYSTOLE AND DEATH. NO FURTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "15436302", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE IS UNKNOWN." } ], "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": "01/27/2017" } ] }