{ "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": "2955842-2018-10773", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20181220", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20180419", "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": "20181220", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1026843", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181220", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI SURGICAL SYSTEM", "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": "", "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": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/27/2020;06/02/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20181220", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "60 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Injury", "Death", "Injury" ] } ], "distributor_city": "", "date_report": "20200327", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8187029", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20181213", "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": "131082259", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSES OF THE INTRA-OPERATIVE COMPLICATION SUSTAINED BY THE PATIENT AND THE PATIENT¿S SUBSEQUENT DEMISE. INTUITIVE SURGICAL, INC. (ISI) HAS CONTACTED THE SITE¿S RISK MANAGEMENT DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE DATE THE DA VINCI-ASSISTED CYSTECTOMY PROCEDURE WAS PERFORMED IS UNKNOWN. IN ADDITION, THE SYSTEM SERIAL # OF THE SPECIFIC DA VINCI SURGICAL SYSTEM USED DURING THE DA VINCI-ASSISTED CYSTECTOMY PROCEDURE IS UNKNOWN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED CYSTECTOMY PROCEDURE, THE PATIENT ALLEGEDLY SUSTAINED AN UNSPECIFIED BOWEL INJURY AND AS A RESULT, THE CASE WAS CONVERTED TO OPEN SURGERY. THE PATIENT REPORTEDLY EXPIRED ON AN UNSPECIFIED DATE. HOWEVER, THE ROOT CAUSES OF THE PATIENT¿S INTRA-OPERATIVE COMPLICATION AND SUBSEQUENT DEATH ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." }, { "mdr_text_key": "131082260", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED BOWEL INJURY. DUE TO THE INTRA-OPERATIVE COMPLICATION, THE SURGICAL PROCEDURE WAS REPORTEDLY CONVERTED TO OPEN SURGERY. ON AN UNSPECIFIED DATE, THE PATIENT REPORTEDLY EXPIRED. THE CAUSE OF THE DEATH WAS NOT PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." }, { "mdr_text_key": "282089679", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS SUPPLEMENTAL REPORT, WITH ADDITIONAL INFORMATION COLLECTED, IS IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED MARCH 6, 2020." }, { "mdr_text_key": "282089695", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A REVIEW OF THE SITE¿S SYSTEM LOGS AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES. THIS SUPPLEMENTAL REPORT, WITH ADDITIONAL INFORMATION COLLECTED, IS IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED MARCH 6, 2020." } ], "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": "04/09/2020;06/19/2020" } ] }