BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 4172222 · Received October 9, 2014

    Report

    Report Number
    1526350-2014-00444
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    August 1, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 04/13/2013 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. THE REPORTED EVENT WAS NOT REPRODUCED DURING TESTING AS THE DEVICE OPERATED AS INTENDED. FURTHER EVALUATION REVEALED BUBBLING / BLISTERING OF THE HEAD AND HANDPIECE HOUSING, RENDERING THE DEVICE NON-REPAIRABLE. A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS IT WAS NOT REPRODUCED DURING TESTING. THE DEVICE HAS NOT BEEN RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ZIMMER AIR DERMATOME II HANDPIECE WAS NOT WORKING. ADDITIONAL CLINICAL FOLLOW UP DETERMINED THE ISSUE OCCURRED PRIOR TO SURGERY AND THERE WAS NO PATIENT HARM OR DELAY REPORTED. ADDITIONALLY, THE DEVICE WILL BE REVIEWED FOR POSSIBLE BUBBLING/BLISTERING OF THE SURFACE COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636908 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1