BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM W ERG HANDLE

    MDR report key: 1211887 · Received October 23, 2008

    Report

    Report Number
    3005075853-2008-02538
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/23/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP RECTUM RESECTION PROCEDURE, AN ERROR CODE 5 APPEARED ON THE DISPLAY OF THE GEN04. THE SURGEON TOOK BACK THE DEVICE THROUGH A METAL TROCAR. THE DEVICE WAS TAKEN OFF THE HANDPIECE AND WAS REASSEMBLED USING THE TORQUE WRENCH. THE TEST MODE AFTERWARDS TOOK MORE TIME THAN NORMAL. THE DEVICE WAS REINSERTED THROUGH THE TROCAR. THE SURGEON NOTICED ON THE MONITOR THAT THE TIP WAS NOT THERE ANY LONGER. THE DEVICE WAS TAKEN OUT. THE TIP COULD NOT BE FOUND IN THE PT. THE SURGEON CHOSE NOT TO DO AN INTRAOPERATIVE RADIOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM W ERG HANDLE LFL ETHICON ENDO-SURGERY, LLC. NA E4L00N

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE