{ "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": "2955842-2012-00095", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20120229", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "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": [ "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120301", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120229", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC ELECTROSURGICAL 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 A6.0P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20120229", "sequence_number_treatment": [ "DA VINCI SI SYSTEM, INSTRUMENT AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cellulitis", "Death", "Septic Shock", "Respiratory Acidosis", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20111227", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2473426", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20111229", "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": "2524936", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY 1 DAY POST-OP, A SUCCESSFUL DA VINCI SI LYSIS OF ADHESIONS PROCEDURE, THE PATIENT EXHIBITED SIGNS OF CELLULITIS AT ONE OF THE TROCAR SITES AND EXPERIENCED DECREASED URINE OUTPUT. A CT SCAN PERFORMED SHOWED THE PATIENT HAD NORMAL GASTROINTESTINAL AND GENITOURINARY TRACT, HOWEVER, WITHIN A FEW HOURS, THE PATIENT'S HEALTH BEGAN TO DETERIORATE AND WAS TAKEN TO THE ICU. SEVERAL SPECIALISTS CONSULTED SUSPECTED THAT THE PATIENT HAD NECROTIZING FASCIITIS AND THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM. THE GENERAL SURGEON CONSULTED FOUND THAT THE PATIENT'S SMALL BOWEL HAD A PERFORATION. THE PATIENT HAD DEVELOPED SEPTIC SHOCK, ACIDOSIS AND EXPIRED. IT IS THE SURGEON'S BELIEF THAT THE INFECTION DEVELOPED BY THE PATIENT WAS VERY ATYPICAL PRESENTATION FOR PERITONITIS AND PERFORATION AND THAT MAYBE THE PATIENT'S IMMUNOSUPPRESSIVE STATUS CAUSED THE EVENT, AS DAMAGE TO THE PATIENT'S BOWEL WAS NOT THERMAL DAMAGE AND WAS NOT CAUSED BY THE TROCAR AS SHE PERFORMED AN OPEN ENTRY. THE DELAY IN REPORTING IS DUE TO AN OVERSIGHT IN INITIAL CAPTURING OF THE COMPLAINT BY ISI CUSTOMER SERVICE." }, { "mdr_text_key": "9605464", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON FEBRUARY 23, 2012, ISI CONTACTED THE RISK MANAGER AT (B)(6) HOSPITAL AND SHE STATED THAT DAMAGE TO THE PATIENT'S BOWEL WAS POSSIBLY INTRODUCED DURING THE DA VINCI SI LYSIS OF ADHESIONS PROCEDURE. HOWEVER, THERE WAS NO MALFUNCTION OF THE DA VINCI SI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY AND SUBSEQUENT DEMISE. THE RISK MANAGER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION STATING HIPPA REGULATIONS PROHIBITED HER FROM PROVIDING ANY OTHER INFORMATION. ISI ADVISED THE RISK MANAGER THAT HIPPA REGULATIONS DO NOT APPLY TO INVESTIGATIONS RELATED TO ADVERSE EVENTS THAT ARE BEING INVESTIGATED AND REPORTED TO THE FDA. HOWEVER, SHE ADVISED THAT SHE WOULD BE OPEN TO DISCUSSING THE REPORTED EVENT WITH THE FDA. AS OF FEBRUARY 29, 2012, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S SYSTEM." } ], "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": "" } ] }