{ "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": "2955842-2017-00268", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20170503", "manufacturer_address_2": "", "pma_pmn_number": "", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20170503", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "322381", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170503", "brand_name": "DA VINCI 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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "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": "20170503", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Unspecified Infection", "Injury", "Death", "Unspecified Infection", "Injury" ] } ], "distributor_city": "", "date_report": "20140403", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6541520", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140403", "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": "74324492", "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 ALLEGED OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THE FOLLOWING INFORMATION IS UNKNOWN: WHAT DATE THE SURGICAL PROCEDURE WAS PERFORMED, WHAT TYPE OF SURGICAL PROCEDURE WAS PERFORMED, WHAT HOSPITAL THE SURGICAL PROCEDURE WAS PERFORMED AT, WHAT SPECIFIC DEVICE ALLEGEDLY NICKED THE PATIENT'S COLON, AND WHAT DATE THE PATIENT REPORTEDLY EXPIRED. IN ADDITION, THE INITIAL REPORTER'S CONTACT INFORMATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE INITIAL REPORTER CLAIMED THAT THE PATIENT'S COLON WAS NICKED BY AN UNSPECIFIED DEVICE WHILE UNDERGOING A DA VINCI-SURGICAL PROCEDURE. AS A RESULT, THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION AND SUBSEQUENTLY EXPIRED. HOWEVER, THE ROOT CAUSES OF THE PATIENT'S ALLEGED OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." }, { "mdr_text_key": "74324493", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED, DURING AN ANONYMOUS CONSUMER SURVEY, THAT THE PATIENT'S COLON WAS ALLEGEDLY NICKED BY AN UNSPECIFIED DEVICE WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE. AS A RESULT, THE INITIAL REPORTER (THE PATIENT'S FRIEND) CLAIMED THAT THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION AND WAS ADMITTED TO THE ICU FOR ABOUT 2 WEEKS BEFORE HE WAS RELEASED TO GO HOME. THE FOLLOWING NIGHT AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT WAS READMITTED TO THE HOSPITAL FOR PAIN AND SUBSEQUENTLY EXPIRED." } ], "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": "" } ] }