BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3850549 · Received May 22, 2014

    Report

    Report Number
    1526350-2014-00362
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS MANUFACTURED ON 04/10/2002 AND WAS LAST REPAIRED ON (B)(4) 2014 FOR PREVENTATIVE MAINTENANCE. THE CUSTOMER DID NOT RETURN THE DEVICE TO ZIMMER SURGICAL FOR EVALUATION AND REPAIR; HOWEVER, THE DEVICE WAS CONFIRMED TO MEET CALIBRATION AND FUNCTIONAL SPECIFICATIONS AFTER REPAIR DURING THE PREVIOUS SERVICE. IT WAS ALSO NOTED THAT ON THE PREVIOUS REPAIR THAT THE WIRING AND SILICONE WERE NON-ZIMMER PARTS, POSSIBLY INDICATING REPAIR FROM A NON-ZIMMER FACILITY. A CAUSE OF THE CUSTOMER'S REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO INFORMATION IS KNOWN REGARDING THE TECHNIQUE OR METHODS UTILIZED DURING THE REPORTED EVENT; HOWEVER, INCORRECT USER TECHNIQUE COULD CAUSE THE DEVICE TO HARVEST AN UNUSABLE GRAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING THE REPAIRED ELECTRIC DERMATOME HANDPIECE FOR THE FIRST TIME AFTER GETTING IT BACK FROM THE REPAIR FACILITY FOR CALIBRATION, IT WAS USED ON A BURN VICTIM WITH LITTLE TISSUE AREA TO USE AND THE TISSUE WAS DESTROYED FROM THE UNIT. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306519 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1