BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3832841 · Received March 17, 2014

    Report

    Report Number
    1526350-2014-00187
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 30, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 JANUARY 22, 1996 AND WAS LAST REPAIRED ON MAY 14, 2013 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THE DEVICE PERFORMED VERY ERRATICALLY WITHIN MOTOR SPEED SPECIFICATIONS. THE LEADING EDGE OF THE CONTROL BAR WAS FLUSH WITH THE MASTER BLADE. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS ONLY AT THE ZERO THICKNESS SETTING. REPAIR OF THE DEVICE INCLUDED THE REPLACEMENT OF THE MOTOR, POWER SUPPLY ASSEMBLY, POWER SWITCH, AND ALL STANDARD REPAIR PARTS. POST REPAIR ANALYSIS REVEALED THAT THE MOTOR OPERATED WITHIN SPECIFICATIONS OUTSIDE OF THE HANDPIECE AND THE SWITCH PASSED CONTINUITY TESTING. ADDITIONALLY, THERE WAS A MINOR DISCOLORATION AND CORROSION OF THE MOTOR CASING . THE CUSTOMER DID NOT RETURN A POWER SUPPLY FOR EVALUATION. GIVEN THE DISCOLORATION AND CORROSION ON THE MOTOR CASING, IT IS LIKELY THAT THE INTERIOR OF THE MOTOR BECAME DAMAGED OVER TIME, WHICH MOST LIKELY CAUSED THE MOTOR TO OPERATE ERRATICALLY, WHICH COULD HAVE CAUSED THE CUSTOMER'S REPORTED EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTRIC DERMATOME HANDPIECE MOTOR WAS NOT UP TO PAR. PRIOR TO BEING USED ON A PATIENT, THE DEVICE DID NOT SOUND LIKE IT WAS GETTING FULL POWER AND THAT THE MOTOR WAS RUNNING SLOW. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT HARM ASSOCIATED WITH THE REPORT AND AN ALTERNATE DEVICE WAS RETRIEVED FOR USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156826 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1