{ "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": "2955842-2014-05742", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141126", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130731", "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": "20141126", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "767581", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141126", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20141126", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "54 YR", "patient_sex": "", "patient_weight": "125", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Abdominal Pain", "Anemia", "Congestive Heart Failure", "Death", "Dyspnea", "Gangrene", "Low Blood Pressure/ Hypotension", "Hypoxia", "Pain", "Renal Failure", "Sepsis", "Septic Shock", "Rupture", "Elevated Ketones/ Diabetic Ketoacidosis", "Respiratory Failure", "Confusion/ Disorientation" ] } ], "distributor_city": "", "date_report": "20141031", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4280711", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141031", "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": "19535704", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THE DATE OF THE PATIENT'S DEATH IS UNKNOWN. 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 HER SUBSEQUENT DEMISE. 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": "19303220", "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 UNDERWENT A DA VINCI ASSISTED LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PROCEDURE ON (B)(6) 2013 FOR MORBID OBESITY. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND PATIENT'S MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. IN ADDITION, THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. ON POST-OPERATIVE DAY (POD) 1, THE PATIENT'S UPPER GI WAS FOUND TO BE NORMAL. THE PATIENT WAS STARTED ON CLEAR LIQUIDS AND ADVANCED TO FULL LIQUIDS AND PROTEIN DRINK, WHICH SHE TOLERATED WELL. ON (B)(6) 2013, THE PATIENT WAS TOLERATING LIQUIDS AND HER CREATININE LEVEL WAS BACK TO BASELINE AT 2.79. THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013, SHE WAS RE-ADMITTED FOR HYDRATION AND DIABETES MANAGEMENT UNTIL BEING DISCHARGED ON (B)(6) 2013. BY (B)(6) 2013, THE PATIENT BEGAN TO DEVELOP INCREASING SHORTNESS OF BREATH, PAIN, CONFUSION AND DISORIENTATION WITH SIGNIFICANT ABDOMINAL DISCOMFORT AND PAIN WITH LOW BLOOD PRESSURE CONSISTENT WITH SEPTIC SHOCK. SHE WAS ADMITTED TO THE ICU FOR MANAGEMENT AND EVALUATION. DIAGNOSTIC ASSESSMENTS INDICATED THAT SHE PROBABLY HAD DEVELOPED AN ACUTE ABDOMEN WITH SEPSIS WITH ACUTE RENAL FAILURE. ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE AN ANASTOMOTIC LEAK. THE PATIENT UNDERWENT A LAPAROSCOPIC RE-EXPLORATION OF THE ABDOMEN, RESECTION AND REVISION OF THE GASTROJEJUNAL ANASTOMOSIS, AND IRRIGATION OF THE ABDOMINAL CAVITY. INITIALLY, THE PATIENT WAS ADMITTED TO INTENSIVE INPATIENT REHABILITATION PROGRAM ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED AND TRANSFERRED TO A HOSPITAL FOR ABDOMINAL PAIN WORK-UP. THAT SAME DAY, THE PATIENT WAS DIRECTLY ADMITTED AND A LAPAROSCOPY PROCEDURE WAS PERFORMED WHICH WAS CONVERTED TO AN OPEN CHOLECYSTECTOMY FOR A COMPLETELY GANGRENOUS GALLBLADDER. POST-OPERATIVELY, THE PATIENT HAD NUMEROUS MEDICAL PROBLEMS NOT LIMITED TO RESPIRATORY FAILURE, HYPOXIA, AND WORSENING CONGESTIVE HEART FAILURE WHICH WAS CONFIRMED ON (B)(6) 2013. ACCORDING TO THE PATIENT'S DEATH SUMMARY DATED (B)(6) 2013, THE ADMISSION DIAGNOSIS WAS UNSPECIFIED SEPTICEMIA. THE DISCHARGE DIAGNOSES WERE SEPTICEMIA, HYPERKALEMIA, ANEMIA, KETOACIDOSIS SECONDARY TO DIABETES, ACUTE ON CHRONIC RENAL FAILURE. SECONDARY DIAGNOSES INCLUDED: BARIATRIC RUPTURE WITH COMPLICATIONS ASSOCIATED ORIGINALLY WITH BARIATRIC SURGERY." } ], "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": "" } ] }