{ "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": "2955842-2014-00357", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20140117", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110607", "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": "20140117", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "44431", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140117", "brand_name": "DA VINCI S 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": "", "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": [ "Leak/Splash" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20140117", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " R" ], "patient_age": "72 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pulmonary Embolism", "Anemia", "Atherosclerosis", "Cardiopulmonary Arrest", "Death", "Fatigue", "Fever", "Hemorrhage/Blood Loss/Bleeding", "Hyperglycemia", "Ischemia", "Necrosis", "Weakness", "Abdominal Distention", "Fibrosis" ] } ], "distributor_city": "", "date_report": "20131219", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3582683", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131219", "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": "17780052", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS AND SUBSEQUENT DEMISE EXPERIENCED BY THE PATIENT. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AND SUBSEQUENTLY PASSED AWAY APPROXIMATELY 3.5 MONTHS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "17390199", "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 THAT UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2011 FOR LOWER ANTERIOR RESECTION FOR OBSTRUCTING RECTOSIGMOID CANCER WHO SUBSEQUENTLY PASSED AWAY ON (B)(6) 2011. ISI WAS NOT PROVIDED WITH THE DA VINCI SURGICAL OPERATIVE REPORT. ADDITIONAL INFORMATION WAS PROVIDED BUT THEY ARE ALL RELATED TO SUBSEQUENT HOSPITALIZATIONS AND NON-ROBOTIC PROCEDURE. ULTIMATELY, THE PATIENT WAS FOUND TO HAVE EXPIRED AT HOME BY HIS SPOUSE ON (B)(6) 2011 AND AN AUTOPSY REPORT WAS INCLUDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE HOSPITAL AUTOPSY'S CLINICAL SUMMARY PROVIDED THE FOLLOWING INFORMATION: THE PATIENT HAD BEEN IN RELATIVELY GOOD HEALTH UNTIL (B)(6) 2011 AT WHICH TIME HE PRESENTED WITH MULTIPLE SYMPTOMS THAT INCLUDED GASTROINTESTINAL BLEEDING, ANEMIA, HYPONATREMIA, HYPERGLYCEMIA, AND FEBRILE ILLNESS. DURING HIS WORKUP, HE WAS ULTIMATELY FOUND TO HAVE NEARLY OBSTRUCTING RECTOSIGMOID MASS, AND UNDERWENT ROBOTIC LOW ANTERIOR RESECTION ON (B)(6) 2011, WITH SPLENIC FLEXURE MOBILIZATION AND UMBILICAL HERNIA REPAIR. PATIENT DID WELL WITH HIS SURGERY, AND WAS DISCHARGED ON (B)(6) 2011, HOWEVER HE WAS READMITTED ON (B)(6) 2011 WITH FEVER AND ABDOMINAL DISTENTION. DURING HIS READMIT HE WAS FOUND TO HAVE AN ANASTOMOTIC SITE LEAK WITH FREE AIR. HE SUBSEQUENTLY UNDERWENT AND EXPLORATORY LAPAROTOMY WITH INCISION AND DRAINAGE, AND WASHOUT OF THE ABDOMINAL CAVITY AND DIVERTING LOOP ILEOSTOMY. HE WAS DISCHARGED ON (B)(6) 2011, AND OVERALL WAS DOING WELL, HOWEVER, HE HAD A (B)(6) LOSS AND FELT FATIGUED. PATIENT WAS SCHEDULED TO HAVE AN ILEOSTOMY REVERSAL ON (B)(6) 2011, HOWEVER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011, WITH A SEVERAL DAY HISTORY OF INCREASED WEAKNESS, DECREASED APPETITE, AND DRY HEAVES. DURING HIS WORKUP, IT WAS DISCOVERED THAT THE ANASTOMIC SITE HAS NOT COMPLETELY HEALED AND AS A RESULT THE ILEOSTOMY REVERSAL WAS POSTPONED. HE WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2011. THE PATIENT'S WIFE DISCOVERED THE PATIENT UNRESPONSIVE IN HIS HOME ON (B)(6) 2011. THE AUTOPSY REVEALED THE PATIENT HAD A MASSIVE BILATERAL PULMONARY EMBOLI AND THE HEART SHOWS SEVERE ISCHEMIC CARDIOPATHY ATHEROSCLEROSIS WITH LARGE AREAS OF FIBROSIS. SECTIONS OF THE LIVER SHOWED CENTRAL LOBULAR NECROSIS, CONSISTENT WITH EPISODE OF HYPOTENSION. THE AUTOPSY SUMMARY IS CONSISTENT WITH CARDIOPULMONARY FAILURE." } ], "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": "" } ] }