{ "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": "2955842-2016-00044", "type_of_report": [ "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20160121", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130910", "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": "20160121", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "42793", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160121", "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": [ "Insufficient Device Problem Information", "Therapeutic or Diagnostic Output Failure", "Insufficient Device Problem Information" ], "reporter_state_code": "WV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;03/09/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20160121", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "58 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Death", "Hemorrhage/Blood Loss/Bleeding", "Sepsis", "Septic Shock", "Bowel Perforation", "Abscess", "Death", "Hemorrhage/Blood Loss/Bleeding", "Sepsis", "Septic Shock", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20151223", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5383198", "removal_correction_number": "", "number_devices_in_event": "", "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": "36525217", "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 ALLEGED POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. 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 DA VINCI SURGICAL PROCEDURE. EACH REUSABLE (MULTI-USE) INSTRUMENT USED DURING THE DA VINCI SURGICAL PROCEDURE HAS BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES WITHOUT ANY REPORTED ISSUES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A BOWEL PERFORATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, DEVELOPED SEPTIC SHOCK POST-OPERATIVELY, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S ALLEGED OPERATIVE COMPLICATIONS AND DEATH ARE UNKNOWN." }, { "mdr_text_key": "36525218", "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 WHO UNDERWENT A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL LOOP DIVERSION AND RADICAL PROSTATECTOMY WITH BILATERAL EXTENDED PELVIC LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2013. AT THE TIME, THE PATIENT WAS SUFFERING FROM PAPILLARY UROTHELIAL CARCINOMA, HIGH GRADE, OF THE BLADDER. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED INJURIES THAT CAUSED HIM TO UNDERGO ADDITIONAL SURGERIES. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE PLAINTIFF'S ATTORNEY, AROUND POST-OPERATIVE DAY 4, THE PATIENT BEGAN EXPERIENCING COMPLICATIONS HIGHLY INDICATIVE OF POSSIBLE BOWEL PERFORATION AND LEAK, WHICH SIGNS AND SYMPTOMS WERE NOT PROPERLY RECOGNIZED AND ADDRESSED UNTIL POST-OPERATIVE DAY FOURTEEN (14). AS A RESULT, THE PATIENT ALLEGEDLY DEVELOPED AN INTRA-ABDOMINAL ABSCESS AND SEPTIC SHOCK, AND ULTIMATELY PASSED AWAY ON (B)(6) 2013." }, { "mdr_text_key": "73916731", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE PLAINTIFF'S ATTORNEY: THE PATIENT'S DEATH CERTIFICATE WAS PROVIDED. ACCORDING TO THE DEATH CERTIFICATE, THE IMMEDIATE CAUSE OF DEATH WAS MULTISYSTEM ORGAN FAILURE. IN ADDITION, THE DEATH CERTIFICATE INDICATES THAT SEQUENTIAL CONDITIONS LEADING TO THE IMMEDIATE CAUSE OF DEATH WERE A COLON PERFORATION AND BLADDER CANCER. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A BOWEL PERFORATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, DEVELOPED SEPTIC SHOCK POST-OPERATIVELY, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S ALLEGED OPERATIVE COMPLICATIONS ARE STILL UNKNOWN." }, { "mdr_text_key": "106187140", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE PLAINTIFF'S ATTORNEY: THE PATIENT UNDERWENT A ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL CYSTECTOMY WITH ILEAL LOOP URINARY DIVERSION; BILATERAL EXTENDED PELVIC LYMPH NODE DISSECTION; ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY FOR BLADDER CANCER ON (B)(6) 2013. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. PER A DEATH SUMMARY, THE PATIENT DID INITIALLY WELL DURING THE FIRST FOUR DAYS POST-OPERATIVELY. ON (B)(6) 2013, FECAL DRAINAGE WAS OBSERVED FROM THE JP DRAIN. A CT SCAN SHOWED NO OBVIOUS BOWEL LEAK OR SIGNIFICANT ABSCESS. SEVERAL DAYS OF BARIUM ENEMAS SHOWED NO SPILLAGE OF CONTRAST. A FEW DAYS LATER, A CT SHOWED CONCERN FOR A BOWEL OBSTRUCTION AND POSSIBLE RECTAL INJURY DISTALLY. ON (B)(6) 2013 THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY. FINDINGS INCLUDED A LARGE AMOUNT OF SMALL BOWEL ADHESED DEEP IN THE PELVIS, A PERFORATION WITHIN THE SMALL BOWEL, AND A LARGE HOLE ALONG THE ANTERIOR PORTION OF THE RECTUM. THE PATIENT UNDERWENT SEGMENTAL SMALL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS AND LOW ANTERIOR RESECTION WITH END COLOSTOMY AND DRAINAGE OF INTRA-ABDOMINAL ABSCESS. THE PATIENT DID WELL INITIALLY AND THEN DEVELOPED PROGRESSIVE MULTISYSTEM ORGAN FAILURE OVER THE NEXT SEVERAL DAYS. THE PATIENT WAS PRONOUNCED DECEASED ON (B)(6) 2013. THE PLAINTIFF'S ATTORNEY ALSO PROVIDED A MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) WITH THE FOLLOWING EVENT DESCRIPTION: PROCEDURE PERFORMED WAS A ROBOTIC ASSISTED RADICAL CYSTECTOMY WITH ILEAL LOOP URINARY DIVERSION USING THE ENDOWRIST ONE VESSEL SEALER. FOUR DAYS AFTER SURGERY, THE PATIENT BEGAN DRAINING FECULENT MATERIAL FROM HIS JP DRAIN. FOLLOWING DIAGNOSTIC TESTING, PATIENT WAS RETURNED TO SURGERY AND A TOTAL COLOSTOMY WAS REQUIRED DUE TO A SUSPECTED THERMAL RECTAL INJURY. THE PATIENT SUCCUMBED TO PROGRESSIVE MULTI-SYSTEM ORGAN FAILURE ON (B)(6) 2013. THE MEDWATCH REPORT WAS REPORTED AGAINST AN ENDOWRIST ONE VESSEL SEALER INSTRUMENT (PART 410322; LOT S10130626). ISI HAS RE-REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. THE LOGS REVEAL THAT WITH THIS PARTICULAR ENDOWRIST ONE VESSEL SEALER INSTRUMENT, THE SURGEON PERFORMED EIGHT SEALS. HOWEVER, THE SURGEON ALSO ENCOUNTERED FIVE CUT FAILURES WHILE USING THE INSTRUMENT. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A BOWEL PERFORATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, DEVELOPED SEPTIC SHOCK POST-OPERATIVELY, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S ALLEGED OPERATIVE COMPLICATIONS ARE STILL 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": "04/27/2017;04/04/2018" } ] }