{ "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": "2955842-2018-10775", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20181220", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20181110", "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", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GB", "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": "1025941", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181220", "brand_name": "DA VINCI XI SURGICAL SYSTEM", "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": "380652-22", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": [ "" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Sepsis", "Blood Loss", "Death", "Sepsis", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20181129", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8187410", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20181129", "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": "131124058", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSES FOR THE ALLEGED POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND THE PATIENT¿S SUBSEQUENT DEMISE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2018. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED PANCREATECTOMY PROCEDURE, THE PATIENT ALLEGEDLY EXPIRED AS A RESULT OF A POST-OPERATIVE BLEED. HOWEVER, THE ROOT CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS AND SUBSEQUENT DEATH ARE UNKNOWN." }, { "mdr_text_key": "131124059", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT 7 DAYS AFTER UNDERGOING A DA VINCI-ASSISTED PANCREATECTOMY (WHIPPLE) PROCEDURE, THE PATIENT ALLEGEDLY EXPIRED AS A RESULT OF A POST-OPERATIVE BLEED. POST OPERATIVELY, THE PATIENT DEVELOPED SEPSIS WITH RAISED BLOOD PRESSURE. AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. ON (B)(4) 2018, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) PROVIDED ADDITIONAL INFORMATION FROM THE LEAD SURGEON REGARDING THE REPORTED ISSUE: THERE WAS NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE SURGICAL PROCEDURE. DURING THE PROCEDURE, THE PATIENT DEVELOPED A SMALL BLEED FROM A VEIN NEAR THE BILE DUCT. THE CSR STATED THAT THERE WAS NO MEDIUM-LARGE CLIP APPLIER INSTRUMENT OR CLIPS AVAILABLE DURING THE PROCEDURE, THEREFORE, THE SURGEON USED A LARGE CLIP APPLIER INSTRUMENT. IT WAS SPECULATED BY THE LEAD SURGEON THAT THE LARGE SIZE OF THE CLIP APPLIER INSTRUMENT MIGHT HAVE CAUGHT THE VESSEL, ALLEGEDLY CAUSING THE BLEED. THE SURGEON APPLIED PRESSURE VIA A SWAB AND MORE CLIPS WERE APPLIED TO ACHIEVE HEMOSTASIS. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THE PATIENT RECOVERED WELL POST-OPERATIVELY. THE PATIENT WAS EATING AND DRINKING AND THE BOWELS HAD OPENED BY POST-OPERATIVE DAY #3. THE PROCEDURE WAS RECORDED ON VIDEO; HOWEVER, THE SURGEON WAS UNSURE IF IT COULD BE PROVIDED TO ISI FOR REVIEW. ON POST-OPERATIVE DAY #7, THE PATIENT WAS REPORTED TO HAVE A HEMOGLOBIN LEVEL OF 10 [G/DL]. FOUR HOURS LATER, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERNAL BLEEDING WITH AN ESTIMATED BLOOD LOSS OF 800 ML. THE SITE ATTEMPTED TO REVIVE THE PATIENT UNSUCCESSFULLY. IT WAS UNSPECIFIED WHAT TYPE OF MEDICAL INTERVENTION, IF ANY, WAS ADMINISTERED AT THE TIME. THE LEAD SURGEON DID NOT BELIEVE THAT THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE POST-OPERATIVE BLEED OR SEPSIS. THE CORONER DETERMINED THAT THE CAUSE OF DEATH WAS A COMPLICATION FROM THE SURGERY. UPON POST-MORTEM, THE SURGEON ALLEGED THAT THE ANASTOMOSIS WAS DETERMINED TO BE UNOBSTRUCTED WITH NO LEAK. THE SURGEON BELIEVED THAT THERE WAS A POSSIBLE PSEUDOANEURYSM. ON (B)(6) 2018, THE CSR REPORTED THAT THE SURGEON DID NOT BELIEVE THAT THE INTRA-OPERATIVE BLEED CAUSED OR CONTRIBUTED TO THE POST-OPERATIVE BLEED. ON (B)(6) 2018, THE CSR PROVIDED FURTHER INFORMATION REGARDING THE REPORTED ISSUE AFTER SPEAKING WITH THE LEAD SURGEON: THE POST-OPERATIVE BLEED WAS IDENTIFIED WHEN THE PATIENT WAS FOUND UNRESPONSIVE IN THE WARD. THE HOSPITAL RESUSCITATION TEAM WAS CALLED AND PROTOCOL WAS FOLLOWED, INCLUDING THE ADMINISTRATION OF CPR. THERE WAS NO SECOND PROCEDURE PERFORMED TO ATTEMPT TO CONTROL THE BLEEDING. THE 800 ML BLOOD LOSS WAS DISCOVERED IN THE ABDOMEN POST-MORTEM. THE SURGEON BELIEVED THAT IT WAS UNUSUAL FOR THE BLEEDING TO HAVE CAUSED THE PATIENT TO CRASH." } ], "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": "" } ] }