BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1121943 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01186
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 31, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RE-DO OF A LAP FUNDOPLICATION PROCEDURE, THE DEVICE WAS BEING USED DURING THE CASE, BUT IT WAS NOTED THAT THERE WAS A STRANGE NOISE BEING EMITTED FROM THE INSTRUMENT. THEREFORE, AS THEY HAVE DONE MANY TIMES BEFORE, THEY TOOK APART AND REASSEMBLED THE INSTRUMENT. AFTER USING AND REMOVING THE TORQUE WRENCH TO TIGHTEN THE INSTRUMENT, IT WAS NOTED THAT THE ACTIVE BLADE HAD BROKEN OFF THE INSTRUMENT AND WAS FOUND LYING ON THE SCRUB NURSES TABLE. THEY HAD NO MORE OF THE DEVICE ON THE SHELF AND HAD TO CONTINUE WITH BI-POLAR. THERE WERE NO ADVERSE PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC NA E4KW8H

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR