BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 19706470 · Received July 9, 2024

    Report

    Report Number
    2955842-2024-16744
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    November 7, 2023
    Report Date
    June 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS (FA). THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS CONFIRMED AND REPLICATED THE CUSTOMER-REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. HOWEVER, THE GRIP TIPS COULD NOT OPEN OR CLOSE ON THE SYSTEM. THE INSTRUMENT GRIP TIPS WERE STUCK EVEN WHEN THE GRIP OPEN LEVER WAS MANUALLY ACTUATED OFF THE SYSTEM. UPON VISUAL INSPECTION, ALL 9 JAW CERAMIC DOTS WERE PRESENT AT THE TIPS. ADDITIONALLY, THE JAW COVER WAS REMOVED DURING IN-HOUSE TESTING, AND THE INSTRUMENT WAS FOUND TO HAVE THE DISTAL PIN THAT NORMALLY GOES INTO THE CRIMPED FITTING, WHICH WAS FOUND BROKEN. THIS FAILURE LIKELY CAUSED THE GRIP TIPS TO BE STUCK. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE CUT ELECTRODE ON THE BOTTOM JAW OF THE GRIP SET. THE ELECTRICAL CONTINUITY WAS TESTED AND PASSED. LOGS DID NOT SHOW ANY SEAL ELECTRODE SHORTED ERRORS. THE INSTRUMENT WAS FOUND TO HAVE A TORN JAW COVER AT THE DISTAL END. THE TEARS MEASURED APPROXIMATELY 0.091" - 0.174" IN LENGTH. NO MATERIAL APPEARS TO BE MISSING. THE INSTRUMENT WAS FOUND TO HAVE SCRATCH MARKS/ABRASIONS ON THE GRIP TIPS. FA INVESTIGATION CONFIRMED THAT THE ARCING WAS CONTAINED BETWEEN THE INSTRUMENT JAWS (ELECTRODES), AND THE THERMAL DAMAGE WAS ONLY ON THE CUT ELECTRODE/SILICONE AND WAS WITHIN AN ACCEPTABLE LEVEL. ARCING IS A KNOWN ARTIFACT OF THE CUTTING FUNCTION WITH RF ENERGY CUT FUNCTIONALITY. THERE IS NO CLAIM OR EVIDENCE THAT THE INSTRUMENT ARCED FROM AN UNINTENDED LOCATION ON THE INSTRUMENT. THE INSTRUMENT WAS TRANSFERRED TO ENGINEERING FOR FURTHER INVESTIGATION, AND THE INITIAL FINDINGS WERE CONFIRMED. THE DISTAL GRIP DRIVE PIN WAS FOUND TO HAVE BROKEN INTO TWO. PER THE LOG REVIEW, THE INSTRUMENT HAD A VERY LONG DURATION OF USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY SURGICAL PROCEDURE, THE SYNSCHROSEAL INSTRUMENT FAILED, IT DID NOT OPEN AND CLOSE THE JAWS. THE CUSTOMER TRIED TO OPEN IT ON THE ARM AND OUTSIDE OF THE PATIENT WITH THE SLIDE, BUT IT SEEMED BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY NOR DELAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT DID NOT CLOSE THE WHEEL. THE CUSTOMER STATED THAT THE SLIDE BUTTON GRIP RELEASE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564995 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 L91211031 0279 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES