{ "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": "2955842-2017-00298", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20170512", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20170419", "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": "20170512", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "344996", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170512", "brand_name": "DA VINCI XI 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": "IS4000 A70P6", "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": "MI", "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": "20170512", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Death" ] } ], "distributor_city": "", "date_report": "20170419", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6563135", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20170419", "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": "75025824", "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 POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2017. 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 AN UNREMARKABLE DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, THE PATIENT DEVELOPED UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND SUBSEQUENTLY EXPIRED. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S POST-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": "75025825", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT AND UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE. THE INITIAL REPORTER DID NOT KNOW IF THE SECONDARY OPERATION WAS RELATED TO THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ON 05/09/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT: THE CSR WAS PRESENT DURING THE ENTIRE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. A PROCTOR WAS PRESENT DURING THE PROCEDURE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INTRA-OPERATIVE COMPLICATIONS. IN ADDITION, THERE WERE NO REPORTED ISSUES WITH THE DA VINCI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE GJ AND JJ TUBES LOOKED GOOD. HOWEVER, THE SURGEON REPORTEDLY VOICED CONCERNS REGARDING THE POUCH THAT HE HAD MADE. THE CSR REITERATED THAT THERE WAS NO ALLEGATION FROM THE SURGEON OR SURGICAL STAFF THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY HAD OCCURRED. THE CSR INDICATED THAT, ON POST-OPERATIVE DAY 1, HE WAS TOLD BY THE SURGEON THAT THE PATIENT LOOKED GOOD. HOWEVER, ON POST-OPERATIVE DAY 2, THE PATIENT BECAME SYMPTOMATIC AND WAS TAKEN BACK TO THE OR. ACCORDING TO THE CSR, THE PATIENT WAS TAKEN BACK TO THE OR A NUMBER OF TIMES TO HAVE A WASH-OUT PERFORMED. THE PATIENT (A MALE OVER 60 YEARS OLD) SUBSEQUENTLY DEVELOPED CARDIAC ISSUES AND ULTIMATELY EXPIRED ON (B)(6) 2017. THE CSR DID NOT KNOW THE CAUSE OF DEATH OF THE PATIENT." } ], "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": "" } ] }