{ "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": "2955842-2016-00908", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20161222", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20161114", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "20161222", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "848605", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20161222", "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": "MI", "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": "20161222", "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": "20161201", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6199542", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20161201", "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": "63132703", "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 COMPLICATION EXPERIENCED BY THE PATIENT AND THE PATIENT'S SUBSEQUENT DEMISE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT REPORTEDLY BECAME SEPTIC AND RETURNED TO THE HOSPITAL. A BOWEL INJURY WAS IDENTIFIED AND REPAIRED. HOWEVER, THE PATIENT SUBSEQUENTLY PASSED AWAY. AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S BOWEL INJURY AND SUBSEQUENT DEATH ARE UNKNOWN." }, { "mdr_text_key": "63132704", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY THAT WAS NOT IDENTIFIED INTRA-OPERATIVELY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS INFORMED ABOUT THE REPORTED EVENT FROM THE SURGEON'S 1ST ASSIST. THE CSR WAS NOT PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. THERE WAS ALSO NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. AFTER THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON AN UNKNOWN DATE. ON (B)(6) 2016, THE PATIENT RETURNED TO THE HOSPITAL AND WAS SEPTIC. AN EXPLORATORY LAPAROTOMY WAS PERFORMED ON THE PATIENT AND A HOLE WAS FOND ON THE TRANSVERSE COLON. PER THE CSR, THE SURGEON INFORMED HIM THAT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, HE WAS NOWHERE NEAR WHERE THE BOWEL INJURY WAS LOCATED. ACCORDING TO THE CSR, THE SITE DOES NOT KNOW WHAT CAUSED THE BOWEL INJURY. HOWEVER, THE CSR INDICATED THAT THE SITE IS SUSPECTING THAT THE BOWEL INJURY OCCURRED DURING INSERTION OF AN OBTURATOR OR INSTRUMENT. THE SURGEON REPORTEDLY INSERTS HIS TROCARS WITH DIRECT VISUALIZATION VIA OPTIVIEW. THE BOWEL INJURY WAS REPAIRED DURING THE EXPLORATORY LAPAROTOMY PROCEDURE. ON (B)(6) 2016, THE PATIENT EXPIRED. THE CSR DID NOT KNOW IF AN AUTOPSY WAS PERFORMED. ON 12/19/2016, ISI CONTACTED THE CSR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CSR SPOKE TO THE SURGEON'S 1ST ASSIST AGAIN ON AN UNSPECIFIED DATE. THE SURGEON'S 1ST ASSIST INDICATED THAT THE SITE BELIEVES THE BOWEL INJURY POSSIBLY OCCURRED TOWARDS THE END OF THE DA VINCI-ASSISTED SURGICAL PROCEDURE WHILE AN OMENTECTOMY WAS BEING PERFORMED. THE CSR EXPLAINED THAT THE SURGEON PERFORMED THE OMENTECTOMY TO POSSIBLY ENSURE THE REMOVAL OF CANCEROUS TISSUE THAT MIGHT HAVE POTENTIALLY SPREAD TO THE OMENTUM. THE CSR REITERATED THAT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE 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": "" } ] }