BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 19627560 · Received June 27, 2024

    Report

    Report Number
    2955842-2024-16364
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    May 7, 2024
    Report Date
    June 3, 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 Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND FOUND TO HAVE STUCK GRIP TIPS. THE TECHNICIAN WAS UNABLE TO OPEN THE GRIP TIPS WITH THE GRIP LEVER OPEN. AFTER OPENING THE HOUSING, THE GRIP RING WAS NOT DISLODGED. NO CERAMIC DOTS WERE MISSING. LOGS SHOW QTY "6" SEAL AND "10" TRANSECT EVENTS WITH QTY "16" "HIGH INITIAL STARTING IMPEDANCE" ERRORS, INDICATING THAT THE USER LIKELY TRIED TO CUT/SEAL TOO THICK TISSUE, RESULTING IN AN ERROR. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. ADDITIONAL OBSERVATION REPORTED BY SITE THAT IS RELATED TO THE PRIMARY FAILURE: THE INSTRUMENT EXHIBITED IMPRECISE MOTION IN THE DURING GRIPPING AND UNGRIPPING. THE GRIP TIPS MOVED WITHIN THE JOINT LIMITS AND IN THE COMMANDED DIRECTION; HOWEVER, A LAG OR DELAY IN THE MOTION THAT WAS OBSERVED. THE GRIP TIPS WOULD NOT OPEN OR CLOSE. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE THAT ARE NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT: 1). THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED JAW COVER AT THE DISTAL END. THE JAW COVER WAS OFF ONE OF THE DISTAL WASHERS. NO DISTAL WASHERS MISSING. 2). THE INSTRUMENT WAS FOUND TO HAVE TEARS TO THE JAW COVER ON THE DISTAL SIDE OF THE DISTAL WASHER. 3). THE INSTRUMENT WAS ALSO FOUND TO HAVE BROKEN SNAPS OF THE HOUSING. THE INSTRUMENT WAS TRANSFERRED TO ENGINEERING FOR FURTHER INVESTIGATION: INITIAL FINDINGS WERE CONFIRMED. THE INSTRUMENT WAS CONFIRMED TO HAVE GRIPS TIPS STUCK. THE JAW COVER WAS REMOVED, AND IT WAS NOTED THAT THE DISTAL GRIP DRIVE PIN WAS BROKEN INTO TWO. PER LOGS, THE INSTRUMENT WAS USED FOR AN HOUR AND HAD 2 COAG, 169 SEAL AND 146 TRANSECT EVENTS. THE ROOT CAUSE IS ATTRIBUTED TO AN ISSUE WITH MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA IPOM SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815810 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 K11240307 0322 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES