BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 2012183 · Received January 31, 2011

    Report

    Report Number
    1526350-2011-00016
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR. THE SVC RECORDS INDICATE THE DEVICE IS 4 YEARS OLD AND HAS NOT RECEIVED CALIBRATION AND PREVENTATIVE MAINTENANCE SVC AT ZIMMER SURGICAL SINCE ITS PURCHASE IN 2006. A VISUAL INSPECTION FOUND THE MACHINE HEAD HAD DAMAGE THAT PREVENTED THE BLADE FROM SITTING FLUSH EASILY. IN ADDITION, THE DEVICE WAS FOUND TO BE OUT OF CALIBRATION. THE MOST LIKELY CAUSE OF THE REPORTED ISSUE IS THE BLADE NOT BEING PROPERLY SEATED IN THE HAND-PIECE DUE TO DAMAGE TO THE MACHINE HEAD AND LACK OF PREVENTATIVE MAINTENANCE. THE IFU STATES "THE ZIMMER ELECTRIC DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTATIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY." THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ELECTRIC DERMATOME INTERRUPTS DURING WORKING. ADDITIONAL CLINICAL F/U WITH THE HOSPITAL ON (B)(6) 2011 INDICATED THAT THERE WAS NO APPARENT HARM OR INJURY TO THE PT. INFO RECEIVED ON (B)(6) 2011 INDICATED THAT THERE WAS A 2 HR INCREASE IN SURGICAL TIME DUE TO THE DERMATOME. THE FACILITY HAD NO OTHER UNIT ON SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1