BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME POWER SUPPLY

    MDR report key: 2172575 · Received July 20, 2011

    Report

    Report Number
    1526350-2011-00156
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE RECORD INDICATES THAT THE DEVICE IS (B)(6) OLD, THE LAST REPAIR WAS ON (B)(6) 2010. THE INSPECTION FOUND THAT THE DEVICE PASSED ALL PERFORMANCE TESTING; HOWEVER, THE MOTOR WAS FAULTY. THE CAUSE OF THE REPORTED COMPLAINT WAS A FAILING HANDPIECE MOTOR. EXAMINATION OF THE DEVICE SHOWED CORROSION ON THE EXTERIOR OF THE MOTOR, WHICH WOULD INDICATE MOISTURE INTRUSION INTO THE INNER MOTOR. THE MOTOR SHAFT WOULD NOT TURN. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ELECTRIC DERMATOME DEVICE WAS INVOLVED IN AN UNTOWARD INCIDENT. USER REPORTS THE SHAVER STOPPED WORKING IN "MID-USE." ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE DEVICE CREATED A PARTIAL THICKNESS SKIN GRAFT WHICH WAS SUTURED BACK ONTO DONOR SITE. AN ALTERNATE AVAILABLE UNIT WAS USED TO COMPLETE THE PLANNED SPLIT THICKNESS SKIN GRAFT PROCEDURE WITH ONLY MINIMAL INCREASE OF SCHEDULED SURGICAL TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1