{ "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": "2955842-2021-10550", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210521", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210426", "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": "20210521", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "763613", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210521", "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": "L90200813 0153", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210513", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)220831(10)L90200813", "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": "05/20/2021", "mfr_report_type": "", "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": "20210521", "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": "20210426", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11867995", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210426", "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": "324433789", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "324433790", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D02 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. VISUAL INSPECTION IDENTIFIED THERMAL DAMAGE ON THE CUT ELECTRODE LOCATED ON THE BOTTOM JAW OF THE GRIP SET. AS PART OF INVESTIGATION, THE INSTRUMENT WAS TESTED AND PASSED ALL SPECIFICATION. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. ALL 9 JAW CERAMIC DOTS WERE CONFIRMED PRESENT AT THE TIPS. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY. A REVIEW OF LOGS SHOWED NO FAILURES. THE ROOT CAUSE OF THE THERMAL DAMAGE ON THE CUT ELECTRODE IS ATTRIBUTED TO A COMPONENT FAILURE." }, { "mdr_text_key": "265808141", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT RECEIVED THE SYNCHROSEAL INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE OF THE SYNCHROSEAL INSTRUMENT IDENTIFIES SOME THERMAL DAMAGE ON THE CUT ELECTRODE DUE TO ARCING. THERMAL DAMAGE TO THE CUT ELECTRODE WILL MOST LIKELY NOT CAUSE A FRAGMENT, AS THE ARC ESSENTIALLY VAPORIZES OR MELTS THE CUT ELECTRODE & OVERMOLD MATERIAL. ASIDE FROM BEING DIRTY, THERE DOES NOT SEEM TO BE ANY OTHER DAMAGE OR MISSING MATERIAL ON THE INSTRUMENT. FSE NOTED THAT \"ARCS THAT REMAIN BETWEEN THE JAWS OF THE INSTRUMENT ARE AN EXPECTED CONDITION OF THE INSTRUMENT¿S BIPOLAR CUT (TRANSECT/SYNC) FUNCTION. FREQUENCY/OCCURRENCE OF THESE EVENTS IS DEPENDENT ON A NUMBER OF FACTORS, SUCH AS TISSUE TYPE, TISSUE AMOUNT/THICKNESS, FLUID PRESENT, ETC. THE CUT ELECTRODE THERMAL DAMAGE IS MOST LIKELY NOT DUE TO USER MISHANDLING.\" TECHNICAL REVIEW WAS PERFORMED BY THE ISI FAE. ACCORDING TO THE FAE THE COMPLAINT INFORMATION ACKNOWLEDGES THAT THE SYSTEM DISPLAYED AN ERROR PROMPT WITH A RED TRIANGLE DURING INTRAOPERATIVE USE. THE ISI FAE INDICATED THAT WHEN THE E-100 GENERATOR DETECTS AN ARC OR A SHORT BETWEEN THE CUT ELECTRODE DUE TO INTERFERING MATERIAL, IT WILL RESTRICT ENERGY DELIVERY AND DISPLAY A WARNING MESSAGE TO THE USER. EXCERPTS FROM THE INSTRUCTIONS FOR USE (IFU) INDICATES THE FOLLOWING. POSSIBLE JAW DAMAGE. IF THE GENERATOR DETECTS AN ARC DURING ENERGY ACTIVATION, IT STOPS APPLYING ENERGY, PRODUCES AN ERROR TONE, AND INDICATES AN INCOMPLETE ACTIVATION CYCLE. IFU REMINDS THE USER TO \"INSPECT THE INSTRUMENT JAWS FOR POSSIBLE DAMAGE BEFORE REAPPLYING ENERGY.\" INTERFERING MATERIAL. IF THE GENERATOR DETECTS AN INTERFERING MATERIAL (I.E. EXCESS FLUID, METAL STAPLES, OR METAL CLIPS) IN THE JAWS DURING ENERGY ACTIVATION, IT STOPS APPLYING ENERGY, PRODUCES AN ERROR TONE, AND INDICATES AN INCOMPLETE SEAL CYCLE. IFU REMINDS THE USER TO \"REMOVE ANY INTERFERING MATERIAL FROM THE SEAL AREA BEFORE REAPPLYING ENERGY.\" A PROCEDURE LOG REVIEW WAS EXECUTED TO VERIFY THE PROCEDURE NAME AND ADDITIONAL INSTRUMENT DETAILS IDENTIFYING THE USAGE LOG FOR SYNCHROSEAL INSTRUMENT LOT# L90200813 / SEQUENCE 0153. A REVIEW OF THE INSTRUMENT LOG USING THE OBTAINED INSTRUMENT DETAILS WAS PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON THE REPORTED EVENT DATE OF (B)(6)2021 ON SYSTEM (B)(4). THE INSTRUMENT IS SINGLE-USE, THEREFORE NO SUBSEQUENT USE IS RECORDED. A REVIEW OF THE COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THE PRODUCT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE ADVERSE EVENT AND MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: SYNCHROSEAL IS A BIPOLAR ELECTROSURGICAL INSTRUMENT FOR USE WITH A COMPATIBLE DA VINCI SURGICAL SYSTEM AND A COMPATIBLE ELECTROSURGICAL GENERATOR. IT IS INTENDED FOR GRASPING, DISSECTION, SEALING AND TRANSECTION OF TISSUE. SYNCHROSEAL CAN BE USED TO SEAL VESSELS UP TO AND INCLUDING 5MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS DAMAGED, A PIECE POSSIBLY FELL INSIDE THE PATIENT, AND WAS NOT FOUND. AT THIS TIME, THE LOCATION OF THE MISSING INSTRUMENT FRAGMENT IS UNKNOWN AND IT IS UNCLEAR IF THE FRAGMENT ACTUALLY FELL INSIDE THE PATIENT AND WAS RETAINED. IN ADDITION, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE REMAINS UNKNOWN." }, { "mdr_text_key": "265808142", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS USED FOR A SURGICAL TASK AND AN ISSUE WAS OBSERVED. ALLEGEDLY, \"THE SIDE OF THE ELECTRODE FOR CUTTING THE SYNCHROSEAL INSTRUMENT WAS MISSING DURING THE PROCEDURE.\" THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE PROCEDURE STATED THAT THE SURGEON OBSERVED A SYSTEM PROMPT (RED TRIANGLE ERROR MESSAGE), INSPECTED THE INSTRUMENT AND IDENTIFIED DAMAGE WITH A \"FAIRLY SMALL PIECE\" MISSING, AND ELECTED TO HAVE THE INSTRUMENT REMAIN IN USE BASED ON THE SURGEON'S DISCRETION. AFTER THE SURGICAL TASK, THE USER FURTHER INSPECTED THE INSTRUMENT AND MADE AN ATTEMPT TO INSPECT AND LOCATE IF A FRAGMENT WAS RETAINED INSIDE THE PATIENT'S BODY AND DID NOT FIND ANYTHING. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ISI FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUE WAS FOUND. IT WAS CONFIRMED THAT THE SURGEON ALREADY HAD KNOWLEDGE ABOUT A POTENTIAL ISSUE, WAS AWARE OF A SYSTEM ALERT, AND STILL ELECTED TO USE THE INSTRUMENT. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). NO KNOWN INSTRUMENT COLLISION OCCURRED. NO ADDITIONAL SURGICAL PROCEDURE HAS BEEN PERFORMED AT THIS TIME. NO POST-OPERATIVE TESTS SUCH AS X-RAY OR ULTRA SOUND WERE REQUIRED. IT REMAINS UNKNOWN WHETHER A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETAINED." } ], "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": "06/13/2021" } ] }