{ "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": "I", "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": "2955842-2019-10280", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20190418", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20190320", "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 REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190418", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "322818", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190418", "brand_name": "DA VINCI SI", "generic_name": "PATIENT SIDE CART, 4-ARM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380614-10", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "ME", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/16/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20190418", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "83", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Injury", "Death", "Injury" ] } ], "distributor_city": "", "date_report": "20200316", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8527896", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190327", "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": "315678794", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 16-MAR-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT: PATIENT AGE: 74 YEARS. PATIENT WEIGHT: 83 KG. PATIENT GENDER: FEMALE. PATIENT DATE OF DEATH: (B)(6) 2019. THE CAUSE OF DEATH, PATIENT MEDICAL HISTORY, AND RELEVANT TESTS WERE REQUESTED BUT WERE NOT AVAILABLE. THIS SUPPLEMENTAL REPORT, WITH ADDITIONAL INFORMATION COLLECTED, IS IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED MARCH 6, 2020." }, { "mdr_text_key": "142373872", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE OPERATIVE COMPLICATION EXPERIENCED CANNOT BE DETERMINED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2019. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PUNCTURE WOUND ON THE PATIENT¿S SIGMOID COLON WAS FOUND. AS A RESULT, THE PATIENT UNDERWENT A BOWEL RESECTION PROCEDURE VIA OPEN SURGERY. THE PATIENT SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE POST-OPERATIVELY AND THE SURGEON BELIEVE THE PATIENT'S DEATH WAS RELATED TO THE BOWEL INJURY. THE SURGEON DID NOT KNOW THE ROOT CAUSE OF THE OPERATIVE COMPLICATION." }, { "mdr_text_key": "142373873", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE, A PUNCTURE WOUND WAS FOUND ON THE PATIENT'S SIGMOID COLON. THE PATIENT WAS REPORTEDLY STILL IN THE HOSPITAL. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. NO INTRA-OPERATIVE COMPLICATIONS WERE IDENTIFIED. THERE WERE ALSO NO REPORTS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. ON POST-OPERATIVE DAY #1, THE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) AND A PUNCTURE WOUND ON THE SIGMOID COLON WAS IDENTIFIED. A BOWEL RESECTION WAS PERFORMED BY A COLORECTAL SURGEON TO ADDRESS THE BOWEL INJURY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE CSR WAS INFORMED THAT THE PATIENT ULTIMATELY EXPIRED. THE CSR SPOKE TO THE SURGEON ABOUT THE POST-OPERATIVE COMPLICATION (I.E. BOWEL INJURY). ACCORDING TO THE CSR, THE SURGEON DID NOT KNOW THE POSSIBLE CAUSE OF THE BOWEL INJURY WHICH WAS RELATED TO THE PATIENT¿S SUBSEQUENT DEMISE." } ], "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": "04/10/2020" } ] }