{ "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": "Injury", "report_number": "2955842-2020-10955", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200923", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20200814", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "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": "", "manufacturer_contact_area_code": "", "date_added": "20200923", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1039913", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200923", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "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": "480440-05", "catalog_number": "480440", "lot_number": "T90200109-0085", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00886874117309", "udi_public": "(01)00886874117309(17)220131(10)T90200109", "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": "Initial", "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": "20200923", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pseudoaneurysm", "No Code Available", "Pseudoaneurysm", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200824", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10571432", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200824", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "208320305", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE ALLEGED OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE SITE HAS DISCARDED THE SYNCHROSEAL INSTRUMENT. THEREFORE, THE INSTRUMENT IS NOT AVAILABLE FOR RETURN TO ISI FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED ABOUT THE EVENT. THE SYNCHROSEAL USER MANUAL PROVIDES THE FOLLOWING WARNING: \"WARNING: USE CARE, AS THERMAL SPREAD ADJACENT TO TARGET TISSUE MAY RESULT IN UNINTENDED BURNS TO SURROUNDING TISSUE.\" A REVIEW OF THE SYSTEM 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, WITH THE EXCEPTION OF THE FOLLOWING: VESSEL SEALER EXTEND (PART #480422-01; LOT #L92200226-0095) IS A SINGLE-USE INSTRUMENT AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. SUCTION IRRIGATOR (PART #470401-06; LOT #M10191224-0050) IS A SINGLE-USE INSTRUMENT AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. AS OF 22-SEP-2020, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED PANCREATICODUODENECTOMY PROCEDURE, A PSEUDOANEURYSM ALLEGEDLY OCCURRED DUE TO A POST-OPERATIVE PANCREATIC LEAK. ALTHOUGH NO MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE POST-OPERATIVE PANCREATIC LEAK, IVR WAS REPORTEDLY PERFORMED FOR THE PSEUDOANEURYSM. THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "208320306", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PANCREATICODUODENECTOMY PROCEDURE, A PSEUDOANEURYSM ALLEGEDLY OCCURRED DUE TO A POST-OPERATIVE PANCREATIC LEAK. IT WAS NOTED THAT A BRANCHED BLOOD VESSEL FROM THE SUPERIOR MESENTERIC ARTERY (SMA) HAD ¿BEEN LEFT CUT OFF BY THE SYNCHROSEAL¿ INSTRUMENT AFTER SEALING AND A PANCREATIC LEAK OCCURRED IN THE SURROUNDING AREA. FURTHERMORE, THE TISSUE TREATED WITH THE SYNCHROSEAL INSTRUMENT WAS BURNED AND APPEARED WHITE. IT WAS SUSPECTED THAT IT WAS DUE TO DAMAGE TO ¿J1V¿ (FIRST JEJUNAL VEIN). THE SURGEON COMMENTED THAT HE/SHE SHOULD HAVE USED THE SYNCHROSEAL INSTRUMENT WITH CAUTION. ON 27-AUG-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, THE SITE CANNOT PROVIDE THE VIDEO TO ISI FOR REVIEW. IT WAS EXPLAINED THAT AFTER A BRANCHED VESSEL FROM THE SMA WAS SEALED COMPLETELY WITH THE SYNCHROSEAL INSTRUMENT, THE SURGEON THEN CUT THE VESSEL. ALTHOUGH IT WAS NOTED THAT THE SITE BELIEVES NO MALFUNCTION OF THE SYNCHROSEAL INSTRUMENT OCCURRED, THE SITE CLAIMS THAT THE SYNCHROSEAL INSTRUMENT HAS A LARGE THERMAL SPREAD TO THE SURROUNDINGS AND THIS IS ¿A FLAW IN THE DEVICE.¿ THE SURGEON COMMENTED THAT THE INSTRUMENT ¿SHOULD BE USED WITH CARE FOR HEAT DIFFUSION AROUND IT BECAUSE THE TIP OF SYCHROSEAL IS BARE METAL.¿ NO MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE PANCREATIC LEAK. ON THE OTHER HAND, ¿IVR¿ (INTERVENTIONAL RADIOLOGY) WAS PERFORMED FOR THE PSEUDOANEURYSM. THE CASE WAS NOT CONVERTED TO OPEN SURGERY AS INITIALLY REPORTED. THE PATIENT¿S CURRENT STATUS WAS NOTED AS ¿STABLE.¿" } ], "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": "" } ] }