BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE

    MDR report key: 3801906 · Received February 11, 2014

    Report

    Report Number
    8031000-2014-00064
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE'S TRIGGER FUNCTION WAS DISABLED. ONCE THE MOTOR WAS STARTED, IT COULD NOT BE SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90057 UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE GEY ZIMMER SURGICAL S.A. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1