{ "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": "I", "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": "2955842-2017-00360", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20170608", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20170324", "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": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20170608", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "407778", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170608", "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 A60P9B", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "IN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20170608", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Sepsis", "Injury", "Death", "Sepsis", "Injury" ] } ], "distributor_city": "", "date_report": "20170514", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6625049", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20170514", "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": "77164516", "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 MDR WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6)2017. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY SUSTAINED A POSSIBLE THERMAL BOWEL INJURY. THE PATIENT SUBSEQUENTLY PASSED AWAY ON POST-OPERATIVE DAY 2. HOWEVER, THE ROOT CAUSE OF THE PATIENT'S OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "77164517", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT'S INTESTINES WERE ALLEGEDLY NICKED AND THE PATIENT PASSED AWAY WITHIN 48 HOURS FROM SEPTIC POISONING. ON (B)(6)2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THE DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE WAS COMPLETED WITH NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. DURING THE SURGICAL PROCEDURE, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY WAS REPORTED. TO HIS RECOLLECTION, THE CSR INDICATED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY THE SURGICAL PROCEDURE WAS PERFORMED. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT CAME BACK TO THE HOSPITAL FOR AN UNKNOWN REASON. THE CSR SPOKE TO THE SURGEON ABOUT THE REPORTED EVENT. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE PATIENT SUPPOSEDLY SUSTAINED A BOWEL INJURY AND THEN PASSED AWAY. THE SURGEON DID NOT INITIALLY ALLEGE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6)2017, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT HAD EXTENSIVE ADHESIONS THAT REQUIRED 90 MINUTES OF LYSIS IN ORDER FOR THE SURGEON TO ACCESS THE TARGET ANATOMY. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. PRIOR TO CLOSURE, THE SURGEON THOROUGHLY INSPECTED THE PATIENT'S ABDOMEN AND NO EVIDENCE OF AN INJURY WAS DETECTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POST-OPERATIVE DAY 1. ON POST-OPERATIVE DAY 2, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT EXPIRED THAT SAME DAY. ACCORDING TO THE RISK MANAGER, THE AUTOPSY REPORT INDICATED THAT THE PATIENT EXPIRED FROM ASPIRATION SECONDARY TO A POSSIBLE PERFORATION INJURY TO THE JEJUNUM. THE PATIENT WAS ALSO NOTED TO HAVE PERITONITIS. THE RISK MANAGER INDICATED THAT AN INTERNAL INVESTIGATION AT THE SITE DETERMINED THAT THE BOWEL INJURY WAS POSSIBLY A THERMAL INJURY THAT WAS NOT DETECTED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. NO OTHER CLINICAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }