BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3823808 · Received February 20, 2014

    Report

    Report Number
    1526350-2014-00100
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 21, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 05/16/2002 AND WAS LAST REPAIRED ON 06/28/2013 FOR INTERMITTENT OPERATION. EVALUATION OF THE DEVICE OBSERVED THAT THE ELECTRIC DERMATOME HAND PIECE OPERATED ERRATICALLY, BUT WITHIN MOTOR SPEED SPECIFICATIONS WITH THE REPAIRS DEPARTMENT POWER SUPPLY, AND CEASED TO OPERATE WITH THE CUSTOMER'S POWER SUPPLY, AFTER ONE POWER CYCLE. IT WAS ALSO NOTED THAT THE SLIDE SWITCH WAS CATCHING AND NOT FUNCTIONING SMOOTHLY. PRIOR TO REPAIR, THE ELECTRIC DERMATOME HANDPIECE WAS OUTSIDE OF CALIBRATION SPECIFICATIONS ONLY AT THE ZERO THICKNESS SETTING. THE POWER SUPPLY RETURNED BY THE COSTUMER MET ALL FUNCTIONAL SPECIFICATIONS AND REPLACEMENT OF PARTS WAS NOT NECESSARY. GIVEN THE CORROSION ON THE MOTOR CASING, IT IS LIKELY THAT THE INTERIOR OF THE MOTOR BECAME DAMAGED AS WELL. IMPROPER HANDLING RELATED TO CLEANING OR STERILIZATION LIKELY ALLOWED MOISTURE TO ENTER THE HANDPIECE, MOST LIKELY CAUSING THE CORROSION TO THE MOTOR, WHICH MOST LIKELY CAUSED THE CUSTOMER'S CLEANING OR STERILIZATION PRACTICES; HOWEVER, IMPROPER CLEANING OR STERILIZATION COULD HAVE USED THE CORROSION ON THE MOTOR, WHICH COULD DAMAGE THE INTERIOR OF THE MOTOR. IMPROPER HANDLING MOST LIKELY CAUSED THE DAMAGE TO THE SLIDE SWITCH OF THE THROTTLE LEVER. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ZIMMER ELECTRIC DERMATOME WAS STOPPING/STARTING DURING USE. IT WAS NOTED THAT THE SWITCH MECHANISM WAS NOT WORKING. PROPERLY/WORN OUT. NO ADDITIONAL CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT. IT ADDITIONAL INFO IS RECEIVED, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106757 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)