BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 3915810 · Received June 12, 2014

    Report

    Report Number
    1526350-2014-00377
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NO RETURNED TO THE MFR FOR EVAL. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME II HANDPIECE WOULD STOP SUDDENLY WHEN IN USE AND WOULDN'T RESTART. WHEN IT WAS TESTED AFTER OPERATION IT STARTED TO WORK AND STOPPED INTERMITTENTLY, SECONDARY TESTING IN THE OFFICE PRODUCED A RESULT THAT SHOWED THE DEVICE WORKED PROPERLY. IT WAS REPORTED THAT THE SURGEON HAD TO OBTAIN AN ALTERNATE DEVICE TO COMPLETE THE SURGERY. ADD'L INFO DETERMINED THAT THE ISSUE OCCURRED DURING SURGERY; HOWEVER THERE WAS NO PT HARM OR SURGICAL DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346567 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1