BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 2971727 · Received January 30, 2013

    Report

    Report Number
    1526350-2013-00041
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 12/14/2011 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. THE INSPECTION FOUND THAT THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT THE ZERO THICKNESS SETTING ON THE LEFT AND RIGHT SIDE. THE UNIT WAS ALSO OUTSIDE CALIBRATION SPECIFICATIONS ON THE LEFT SIDE AT THE 0.01 AND 0.02 THICKNESS SETTINGS. THE UNIT WAS ALSO OUTSIDE OF THE SIDE TO SIDE SPECIFICATIONS AT ZERO, 0.01 AND 0.02 THICKNESS SETTINGS. THE MOTOR WOULD NOT RUN. POST REPAIR TESTING NOTED THAT THERE WAS CORROSION ON THE OUTSIDE OF THE MOTOR CASING. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTIVE MAINTENANCE AND HANDLING ACCORDING TO THE INSTRUCTIONS FOR USE. THE ZIMMER ELECTRIC DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTIVE 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 DERMATOME AUTOMATICALLY SWITCHED OFF. ADDITIONAL CLINICAL FOLLOW-UP WITH THE HOSPITAL INDICATED THAT THE REPORTED EVENT WAS NOTED DURING PROCEDURE SET-UP. AN ALTERNATE UNIT WAS USED FOR THE PLANNED PROCEDURE. THERE WAS NO REPORT OF HARM, INJURY, DELAY, INCREASED SURGICAL TIME, OR MEDICAL/SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41838 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1