BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3187191 · Received June 20, 2013

    Report

    Report Number
    1526350-2013-00326
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 03/04/2011 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. THE POWER SUPPLY WAS MANUFACTURED ON 09/21/1992 AND WAS LAST REPAIRED ON 02/03/2006. EVALUATION OF THE ELECTRIC DERMATOME OBSERVED THAT THE MOTOR WAS RUNNING WITHIN SPECIFICATIONS. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT THE ZERO THICKNESS SETTING ON THE LEFT SIDE AND THE SIDE TO SIDE CALIBRATION. EVALUATION OF THE POWER SUPPLY OBSERVED THAT THE VOLTAGE OUTPUT WAS OUTSIDE OF THE SPECIFIED RANGE. IMPROPER HANDLING MOST LIKELY CAUSED LACK OF CALIBRATION IN THE HAND PIECE AND LACK OF PREVENTATIVE MAINTENANCE MOST LIKELY CAUSED THE POWER SUPPLY TO BE OUTSIDE OF VOLTAGE SPECIFICATIONS. THE LOW VOLTAGE OUTPUT MOST LIKELY CAUSED THE CUSTOMER'S EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ELECTRIC DERMATOME WOULD STOP WORKING WHILE TAKING A SKIN GRAFT, AND WOULD DAMAGE THE GRAFT. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THE REPORTED ISSUE OCCURRED DURING SURGERY AND AN ALTERNATE DEVICE WAS AVAILABLE FOR IMMEDIATE USE. IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED BY AN UNSPECIFIED AMOUNT OF TIME. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281930 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ELECTRIC DERMATOME POWER SUPPLY: 00-8821-006-00| SN # (B)(4)