{ "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": "Injury", "report_number": "2955842-2021-10513", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210515", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210415", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20210515", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200814", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "726072", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210515", "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": "T91200814 0140", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)220831(10)T91200814", "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": "04/21/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250807", "health_professional": "", "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": "20210515", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "64 YR", "patient_sex": "Male", "patient_weight": "93 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210421", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11830116", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210421", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "336862747", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1: B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO \"REQUIRED INTERVENTION\". H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." }, { "mdr_text_key": "336862748", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "250931654", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SYNCHROSEAL INSTRUMENT HAS BEEN DISCARDED BY THE SITE, SO FAILURE ANALYSIS OF THE INSTRUMENT CANNOT BE PERFORMED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND THIS EVENT. A REVIEW OF THE INSTRUMENT LOG FOR THE SYNCHROSEAL INSTRUMENT (PART # 480440-05/LOT # T91200814-0140) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS USED ON (B)(6) 2021 ON SYSTEM SL0273. THIS IS A SINGLE USE INSTRUMENT. THE SITE PROVIDED TWO SHORT VIDEO CLIPS FROM THE PROCEDURE. IN THE FIRST VIDEO, A GRASPER PICKS UP A SMALL, ROUND, WASHER-SHAPED COMPONENT THAT WAS VISIBLY SITTING ON TOP OF PATIENT ANATOMY. THE COMPONENT IS VISUALLY INSPECTED THROUGH THE ENDOSCOPE. IN THE SECOND VIDEO, THE JAW PROFILE OF THE SYNCHROSEAL IS INSPECTED. A SIMILAR-LOOKING COMPONENT CAN BE PARTIALLY SEEN NEAR THE JAWS, BUT VIDEO ANALYSIS ALONE CANNOT CONFIRM THAT IT IS THE SAME COMPONENT THAT WAS LATER PICKED UP. IT IS DIFFICULT TO GAIN FURTHER INFORMATION FROM THE SHORT CLIPS PROVIDED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. SYNCHROSEAL IS AN ADVANCED BIPOLAR INSTRUMENT THAT PROVIDES A UNIQUE ENERGY MODE TO ENABLE SEALING AND TRANSECTION OF VESSELS AND TISSUE BUNDLES WITH A SINGLE PEDAL PRESS. IN ADDITION TO THIS FUNCTIONALITY, SYNCHROSEAL HAS THE ABILITY TO GRASP, DISSECT AND SPOT COAGULATE TISSUE, AND TO INDEPENDENTLY SEAL VESSELS. SYNCHROSEAL, WHEN USED WITH A COMPATIBLE ELECTROSURGICAL GENERATOR, CREATES A SEAL AND TRANSECTS TISSUE BY APPLICATION OF RADIOFREQUENCY (RF) ENERGY TO VESSELS AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. ELECTRODE SEALING SURFACES AND A CUT ELECTRODE WITHIN THE JAWS ENABLE SEALING AND CUTTING. 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 LIVER RESECTION SURGICAL PROCEDURE, A PIECE OF THE SYNCHROSEAL (SMALL, ROUND COMPONENT) FELL OFF THE INSTRUMENT AND LANDED IN THE SITUS. THE PIECE WAS RECOVERED WITHOUT ANY DELAY AND THERE WAS NO HARM TO THE PATIENT. ALTHOUGH THE FRAGMENT WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED UNINTENDED FRAGMENTS FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. WHILE THERE WAS NO HARM OR INJURY TO PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR." }, { "mdr_text_key": "250931655", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, A PIECE OF THE SYNCHROSEAL (SMALL, ROUND COMPONENT) FELL OFF THE INSTRUMENT AND LANDED IN THE SITUS. THE SITE RECOVERED THE PIECE. UNFORTUNATELY, THE PACKAGING WAS ALREADY GONE. THE SITE DISCARDED THE DEVICE, BUT TOOK SNAPSHOTS DURING THE RECORDING OF HOW THE DEFECTIVE PART WAS IN THE BODY. THE PART OF THE INSTRUMENT WAS LOST IN THE PATIENT BUT COULD EASILY BE REMOVED WITHOUT ANY DELAY OR ANY IMPACT ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO THE PROCEDURE AND NO ABNORMALITIES FOUND PRIOR TO INSERTION. THE INSTRUMENT WAS IN USE FOR 8 HOURS. THE INSTRUMENT HAD COLLISIONS WITH OTHER INSTRUMENTS, ON THE SHAFT NOT ON THE TIP. THE SURGEON WAS PERFORMING DISSECTION ON THE STOMACH AND THEN WHEN A CHANGE OF INSTRUMENTS WAS BEING PERFORMED THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. A GRASPER WAS USED TO RETRIEVE THE FRAGMENT. A BIPOLAR INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE TOTAL TIME OF THE PROCEDURE WAS 9 HOURS. NO INFORMATION WAS AVAILABLE REGARDING PATIENT'S CURRENT HEALTH STATUS OR ANY POST-OPERATIVE COMPLICATIONS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/24/2023" } ] }