{ "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": "2955842-2015-00525", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150403", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130307", "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": "20150403", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "220627", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150403", "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": "", "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" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20150403", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " R" ], "patient_age": "83 YR", "patient_sex": "", "patient_weight": "63", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Atrial Fibrillation", "Death", "Low Blood Pressure/ Hypotension", "Hypoxia", "Necrosis", "Renal Failure", "Septic Shock", "Respiratory Failure", "Burn, Thermal", "Multiple Organ Dysfunction Syndrome" ] } ], "distributor_city": "", "date_report": "20150313", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4658374", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150313", "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": "19180468", "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 IS UNKNOWN." }, { "mdr_text_key": "18933290", "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 SIGMOID COLECTOMY ON (B)(6) 2013 FOR ACUTE DIVERTICULITIS AND DIVERTICULAR ABSCESS. THE LEGAL CLAIM ALLEGES THAT THE PATIENT SUSTAINED A THERMAL INJURY TO THE BOWEL, DEVELOPED POST-OPERATIVE SYMPTOMS, AND SUBSEQUENTLY PASSED AWAY. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL PATIENT MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE PATIENT'S MEDICAL RECORDS, SHE PRESENTED TO AN ER ON (B)(6) 2013 WITH COMPLAINTS OF ABDOMINAL PAIN AND NO BOWEL MOVEMENTS OF 4-5 DAYS DURATION. THE PATIENT WAS NOTED TO HAVE A HISTORY OF DIVERTICULITIS AND HAD BEEN HOSPITALIZED RECENTLY FOR TREATMENT OF DIVERTICULITIS. SHE HAD COMPLETED A COURSE OF ORAL ANTIBIOTICS 10 DAYS PRIOR. THE PATIENT WAS ADMITTED IN THE ER WITH DIAGNOSIS OF DIVERTICULAR ABSCESS. AN ABDOMINAL CT-SCAN PERFORMED ON (B)(6) 2013 NOTED A MASS-LIKE THICKENING AT THE DISTAL RECTOSIGMOID AND FLUID COLLECTION IN THE RIGHT HEMIPELVIS NEAR THE RECTOSIGMOID. ANTIBIOTIC TREATMENT FOLLOWED BY SURGICAL INTERVENTION WAS PLANNED. ON (B)(6) 2013, THE PATIENT UNDERWENT THE DA VINCI-ASSISTED SIGMOID COLECTOMY FOR ACUTE DIVERTICULITIS AND DIVERTICULAR ABSCESS. PER THE OPERATIVE REPORT, NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. IN ADDITION, THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. POST-OPERATIVELY, THE PATIENT DEVELOPED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. SHE WAS TREATED SUCCESSFULLY WITH MEDICATION AND CONVERTED TO SINUS RHYTHM. THE PATIENT THEN DEVELOPED SEVERE HYPOTENSION AND HYPOXIA AND WAS TRANSFERRED TO THE ICU ON (B)(6) 2013 FOR SEPTIC SHOCK. THE PATIENT WAS INTUBATED AND PLACED ON A VENTILATOR FOR RESPIRATORY FAILURE. SHE RECEIVED LARGE VOLUME FLUID RESUSCITATION, PRESSORS, WIDE-SPECTRUM ANTIBIOTICS, AND STRESS STEROIDS. ALSO, AN NG TUBE WAS PLACED AND HEPARIN WAS ADMINISTERED AS A PROPHYLAXIS. THE PATIENT REPORTEDLY DEVELOPED ACUTE KIDNEY INJURY, ISCHEMIC ACUTE TUBULAR NECROSIS WITH PROFOUND METABOLIC ACIDOSIS SECONDARY TO SHOCK AND RENAL FAILURE. THE PATIENT ALSO DEVELOPED MULTISYSTEM ORGAN FAILURE AND MODERATE-TO-SEVERE THROMBOCYTOPENIA DUE TO ACUTE ILLNESS. THE PATIENT REQUIRED DIALYSIS AND MULTIPLE BLOOD TRANSFUSIONS. A QUINTON CATHETER WAS PLACED FOR HEMODIALYSIS ON (B)(6) 2013. DESPITE AGGRESSIVE MANAGEMENT, THE PATIENT'S CONDITION CONTINUED TO WORSEN. SHE REMAINED UNRESPONSIVE WHILE ON A VENTILATOR. THE PATIENT'S FAMILY WAS CONSULTED AND THE DECISION WAS MADE FOR NO FURTHER AGGRESSIVE CARE IF THERE WAS NO POSSIBILITY OF FULL RECOVERY TO NORMAL LIFE. THE PATIENT WAS TRANSFERRED TO HOSPICE CARE ON (B)(6) 2013 FOR COMFORT MEASURES. ACCORDING TO THE PATIENT'S DISCHARGE SUMMARY, HER FINAL DIAGNOSIS WAS: DIVERTICULAR ABSCESS; GRAM-NEGATIVE SEPSIS WITH MULTISYSTEM ORGAN FAILURE, ACUTE RESPIRATORY FAILURE, SHOCK LIVER, ATRIAL FIBRILLATION, ACUTE KIDNEY INJURY WITH ACIDOSIS, HYPOTENSION, FLUID OVERLOAD, HYPOXEMIA, SECONDARY THROMBOCYTOPENIA. NO ADDITIONAL MEDICAL RECORDS AFTER (B)(6) 2013 WERE AVAILABLE FOR REVIEW. NO AUTOPSY REPORT OR DEATH CERTIFICATE WAS PROVIDED. THE ACTUAL DATE OF THE PATIENT'S DEATH IS UNKNOWN. BASED ON THE PROVIDED MEDICAL RECORDS, THERE IS NO INDICATION THAT THERMAL BURNS WERE FOUND OR THAT THE BOWEL INJURY SUSTAINED BY THE PATIENT WAS IDENTIFIED OR CAUSED BY THE DA VINCI 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": "" } ] }