{ "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": "2955842-2021-10930", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20210813", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210715", "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": "JA", "manufacturer_contact_area_code": "", "date_added": "20210813", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1217361", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210813", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480440-05", "catalog_number": "480440", "lot_number": "L90201004 0373", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)221031(10)L90201004", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20210813", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20210715", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12317772", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210715", "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": "266369436", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE CUSTOMER HAS DISCARDED THE SYNCHROSEAL INSTRUMENT SO IT WILL NOT BE RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE DEVICE LOGS FOR THE SYNCHROSEAL (PART# 480440-05 / LOT/SERIAL# (B)(4)) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE SYNCHROSEAL WAS LAST USED ON 15-JULY-2021 VIA SYSTEM SERIAL# (B)(4). THIS DEVICE IS A SINGLE-USE INSTRUMENT AND THEREFORE ONLY HAS ONE USE ALLOTTED TO IT. THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S ONLY ALLOTTED USAGE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. A SYSTEM LOG REVIEW WAS PERFORMED, BUT NO ERRORS RELATED TO THIS EVENT WOULD EXIST IN THE LOGS. THE CUSTOMER CONTINUED TO USE THE INSTRUMENT EVEN AFTER IDENTIFYING THE MISSING INSTRUMENT FRAGMENT. THE SYNCHROSEAL INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER TO DISCONTINUE USE OF A DAMAGED OR BROKEN INSTRUMENT BY THE FOLLOWING STATEMENT: WARNING: DISCONTINUE USE IF ANY DAMAGE OR ABNORMALITY IS OBSERVED DURING USE. EXAMPLES OF INSTRUMENT DAMAGE INCLUDE BROKEN OR BENT JAWS, SCRATCHES OR CRACKS ON THE INSTRUMENT SHAFT, DEFECTS ON THE ELECTRODE SEALING SURFACE, TEARS ON THE JAW COVER, OR CUTS/DAMAGE TO THE INSULATION ON THE WIRES. NEVER USE A DAMAGED OR BROKEN INSTRUMENT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A PIECE OF THE WHITE MATERIAL INSIDE THE JAW OF THE SYNCHROSEAL WAS MISSING. REPORTEDLY, THE MISSING PART WAS VERY SMALL AND THE CUSTOMER WAS UNABLE TO LOCATE IT. IT WAS UNKNOWN IF THE FRAGMENT FELL INSIDE THE PATIENT. NO ADDITIONAL TESTS OR SURGICAL INTERVENTION WERE PERFORMED. HOWEVER, UNINTENDED FRAGMENTS FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE FRAGMENT TO SEPARATE FROM THE SYNCHROSEAL INSTRUMENT, AND THE LOCATION OF THE MISSING FRAGMENT REMAINS UNKNOWN. THE PATIENT HAS NOT RETURNED TO THE SITE DUE TO ANY POST-OPERATIVE COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." }, { "mdr_text_key": "266369437", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A PIECE OF THE WHITE MATERIAL, REPORTED TO BE ABOUT 0.5 MM WAS MISSING FROM INSIDE THE JAW OF THE SYNCHROSEAL. THE SURGEON REPORTEDLY DECIDED TO CONTINUE USING THE PRODUCT, AND FELT THAT SINCE THE MISSING PART WAS VERY SMALL THAT THEY WOULD NOT BE ABLE TO FIND THE MISSING PART. IT WAS UNKNOWN WHETHER THE MISSING FRAGMENT HAD FALLEN INSIDE THE PATIENT OR ELSEWHERE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 27-JULY-2021: IT WAS UNKNOWN IF ANY FRAGMENT FELL INSIDE THE PATIENT AND UNKNOWN IF ANY FRAGMENT WAS RETRIEVED. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WAS PERFORMED TO CHECK FOR RETAINED FRAGMENTS. THE PROCEDURE HAD BEEN IN PROCESS FOR 4 HOURS AND THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR ABOUT 20 MINUTES. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS FOUND. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR. IT WAS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS. THE CUSTOMER NOTED THAT THE INSTRUMENT MIGHT HAVE TOUCHED HARD THINGS LIKE HEMO-CLIPS, HOWEVER IT IS NO KNOWN IF THAT WAS DURING ENERGY ACTIVATION. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA AND DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT HAS BEEN DISCHARGED AND HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE SYNCHROSEAL INSTRUMENT WAS DISCARDED BY THE CUSTOMER." } ], "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": "" } ] }