{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Death", "report_number": "2955842-2024-19825", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20240927", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240227", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20240928", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1060838", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240927", "brand_name": "DA VINCI", "generic_name": "DA VINCI", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "UNKNOWN", "catalog_number": "UNKNOWN", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": "09/24/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250821", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20240927", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Septic Shock", "Hemorrhage/Blood Loss/Bleeding", "Septic Shock" ] } ], "distributor_city": "", "date_report": "20240829", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20328473", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240829", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "352913371", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MEDWATCH REPORT REFLECTS DEATH-ONLY DATA FROM A LITERATURE ARTICLE. NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS, ONLY THAT THE RPD PROCEDURES WERE PERFORMED ON DA VINCI XI AND SI SYSTEMS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. ADDITIONALLY, THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A REVIEW OF THE ARTICLE PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT IN THIS REPORT THAT DIED AFTER ROBOTIC SURGERY WAS PART OF A RANDOMIZED CONTROLLED TRIAL COMPARING ROBOTIC PANCREATICODUODENECTOMY TO OPEN. THERE WAS ONE DEATH IN EACH GROUP, WITH THE PATIENT IN THE ROBOTIC GROUP DEVELOPING A FISTULA AND SUBSEQUENTLY DIED OF SEPTIC SHOCK. THERE IS NO ALLEGATION OF ANY ISSUES OR MALFUNCTIONS RELATED TO THE DA VINCI ROBOT. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT. CITATION: EFFECT OF ROBOTIC VERSUS OPEN PANCREATICODUODENECTOMY ON POSTOPERATIVE LENGTH OF HOSPITAL STAY AND COMPLICATIONS FOR PANCREATIC HEAD OR PERIAMPULLARY TUMOURS: A MULTICENTRE, OPEN-LABEL RANDOMIZED CONTROLLED TRIAL. HTTPS://DOI.ORG/10.1016/S2468-1253(24)00005-0 SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED." }, { "mdr_text_key": "352913372", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REVIEW OF AN ARTICLE WAS COMPLETED OF A RANDOMIZED CONTROLLED TRIAL BASED ON DA VINCI-ASSISTED ROBOTIC PANCREATICODUODENECTOMY (RPD) WHERE THE AUTHORS COMPARED THE SHORT-TERM POSTOPERATIVE OUTCOMES OF RPD WITH THOSE OF OPEN PANCREATICODUODENECTOMY (OPD). THE TRIAL, CONDUCTED BETWEEN MARCH 5 AND DECEMBER 20, 2022, INCLUDED 164 PATIENTS RANDOMLY ASSIGNED TO EITHER THE RPD OR OPD GROUP. IN THE RPD GROUP, THERE WAS ONE IN-HOSPITAL DEATH (1%) WITHIN 90 DAYS AFTER THE OPERATION. SPECIFICALLY, ONE (1%) OF 81 PATIENTS IN THE RPD GROUP DEVELOPED POSTOPERATIVE PANCREATIC FISTULA RELATED HEMORRHAGE ON POSTOPERATIVE DAY 9, UNDERWENT TRANS-ARTERIAL EMBOLIZATION AND A SUBSEQUENT REOPERATION, BUT DIED OF SEPTIC SHOCK ON DAY 30. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED. THE OPD SUBSET ALSO HAD ONE PATIENT DEATH DUE TO A PULMONARY EMBOLISM ON POSTOPERATIVE 5. THE ARTICLE STATES THAT WHILE RPD SHOWED BENEFITS IN REDUCING HOSPITAL STAY, THE OVERALL CLINICAL BENEFIT REMAINS UNCLEAR, ESPECIALLY CONSIDERING THE EXTRA COSTS AND PATIENT PERCEPTIONS OF QUALITY OF LIFE AND RECOVERY AFTER DISCHARGE." }, { "mdr_text_key": "354825098", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "354825099", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SECTION B5: ADDITIONAL INFORMATION WAS RECEIVED FROM THE DESIGNATED AUTHOR WHO RESPONDED THAT NO DEVICE MALFUNCTIONS OCCURRED DURING THE PROCEDURES, AND NO REINTERVENTIONS WERE REQUIRED DUE TO PRODUCT-RELATED ISSUES OR INJURIES. THEY ARE UNABLE TO RELEASE PATIENT INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/22/2024" } ] }