{ "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": "2955842-2014-05890", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20141219", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20141106", "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 representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20141219", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "835494", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141219", "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": "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20141219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L" ], "patient_age": "51 YR", "patient_sex": "", "patient_weight": "85", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20141121", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4348201", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141223", "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": "12672845", "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 HIS OR HER SUBSEQUENT DEMISE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. 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) 2014. DURING THE DA VINCI SURGICAL PROCEDURE, A SYSTEM ERROR CODE 23075 WAS GENERATED ONE TIME. A SYSTEM ERROR CODE 23075 INDICATES THAT THE SYSTEM DETECTED CONDITIONS CONSISTENT WITH THE MASTER TOOL MANIPULATOR (MTM) DRIFTING WHILE THE SURGEONS HEAD IS IN THE CONSOLE. THIS IS TYPICALLY CORRELATED TO THE SURGEON'S HANDS NOT BEING ON THE MASTERS WHILE NORMAL SURGICAL MODE AND IS IN PLACE TO PREVENT THIS TYPE OF USER ERROR. THIS ERROR CODE IS NOT LIKELY TO BE RELATED TO THE COMPLAINT AND SHOWS THAT THE SYSTEM IS WORKING AS INTENDED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: 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." }, { "mdr_text_key": "12763485", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 12/23/2014 AND 01/19/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SITE'S RISK MANAGER: THE PATIENT'S MEDICAL HISTORY CONSISTED OF COAGULOPATHY, PLATELET DISORDER, BLEEDING DISORDER, AND ULCERATIVE COLITIS. THE PATIENT ELECTED TO HAVE THE DA VINCI PROCEDURE AFTER OTHER MEDICAL THERAPIES FAILED. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT OF THE DA VINCI TOTAL PROCTOCOLECTOMY WITH J-POUCH PROCEDURE. BASED ON THE OPERATIVE REPORT, THE SURGICAL PROCEDURE WAS NOT A PLANNED COMBINATION OF DA VINCI-ASSISTED LAPAROSCOPIC SURGERY AND TRADITIONAL LAPAROSCOPIC SURGERY AS NOTED IN THE INITIAL MDR SUBMISSION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. THE DA VINCI SURGICAL PROCEDURE BEGAN AT 2:23 PM. APPROXIMATELY 2.0-2.5 HOURS INTO THE DA VINCI SURGICAL PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL HAND-ASSISTED LAPAROSCOPIC SURGERY IN ORDER TO PERFORM LYSIS OF ADHESIONS. DUE TO DENSE ADHESIONS, CONSTANT BLEEDING, AND THE NEED FOR BETTER VISUALIZATION, THE SURGEON THEN MADE THE DECISION TO CONVERT TO A LAPAROTOMY. THE SURGICAL PROCEDURE WAS COMPLETED AT 11:29 PM. ON POST-OP DAY 1 ((B)(6) 2014), THE PATIENT RETURNED TO THE OPERATING ROOM AND UNDERWENT AN EXPLORATORY LAPAROTOMY AT 6:59 PM TO CONTROL AREAS OF SLOW OOZING OF BLOOD. THE PATIENT RECEIVED ABDOMINAL PACKING AND UNDERWENT A PARTIAL OMENTECTOMY. THE SURGICAL PROCEDURE WAS COMPLETED AT 8:28 PM. A PLANNED 2ND PROCEDURE TO FURTHER EVALUATE THE BLEEDING WAS NOT PERFORMED. THE PATIENT PASSED AWAY ON (B)(6) 2014 AND AN AUTOPSY WAS REFUSED BY THE PATIENT'S FAMILY. ACCORDING TO THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS MULTI-ORGAN FAILURE SECONDARY TO HYPOVOLEMIC SHOCK DUE TO ACUTE BLOOD LOSS AND COAGULOPATHY. ACCORDING TO THE DEATH CERTIFICATE, BOWEL ISCHEMIA WAS A SIGNIFICANT CONDITION CONTRIBUTING TO THE PATIENT'S DEATH BUT WAS NOT RELATED TO THE CAUSE GIVEN. THE RISK MANAGER ATTRIBUTED THE BOWEL ISCHEMIA TO THE PATIENT'S HISTORY OF ULCERATIVE COLITIS. THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: 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 IS UNKNOWN." }, { "mdr_text_key": "5205150", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI TOTAL PROCTOCOLECTOMY WITH J-POUCH PROCEDURE ON (B)(6) 2014, THE PATIENT BLED OUT, HAD ORGAN FAILURE DUE TO BLOOD LOSS, AND PASSED AWAY ON (B)(6) 2014. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE SURGICAL PROCEDURE WAS PLANNED TO BE A COMBINATION OF A DA VINCI TOTAL PROCTOCOLECTOMY WITH J-POUCH AND TRADITIONAL LAPAROSCOPIC SURGERY. AFTER THE DA VINCI PORTION OF THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED, THE SURGEON FINISHED THE REMAINDER OF THE SURGERY VIA TRADITIONAL LAPAROSCOPIC SURGERY. NO INTRA-OPERATIVE COMPLICATIONS OR SIGNIFICANT BLEEDING WERE REPORTED DURING THE SURGERY. IN ADDITION, NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM WAS REPORTED. POST-OPERATIVELY, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY PASSED AWAY ON POST-OP DAY 10. THE INITIAL REPORTER INDICATED THAT HE SPOKE TO VARIOUS SURGEONS AT THE SITE REGARDING THE REPORTED EVENT AND WAS INFORMED THAT THE PATIENT'S BLEEDING WAS DUE TO A PLATELET ISSUE. ACCORDING TO THE INITIAL REPORTER, HE WAS INFORMED BY THE SITE THAT THE PATIENT WAS BLEEDING EVERYWHERE AND THE SOURCE OF THE BLEEDING WAS NOT PINPOINTED OR IDENTIFIED." } ], "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": "01/22/2015" } ] }