BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ECLECTRIC/BATTERY DOUBLT

    MDR report key: 3823800 · Received February 20, 2014

    Report

    Report Number
    8031000-2014-00088
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 24, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE HAD A STUCK MOTOR. AFTER REPLACING THE BATTERY SEVERAL TIMES, THE PROGRAM PERSISTED AND THE UNIT DID NOT TURN ON. THERE WAS NO PT HARM OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106678 UNIVERSAL MODULAR ECLECTRIC/BATTERY DOUBLT UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE GEY ZIMMER SURGICAL S.A. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1