BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T

    MDR report key: 3202163 · Received June 28, 2013

    Report

    Report Number
    8031000-2013-00101
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    IT WAS REPORTED THAT WHEN TESTING THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE ON THE STERILE FIELD PRIOR TO THE PROCEDURE BEGINNING, THE HANDPIECE WOULD NOT WORK. THERE WAS NO NOISE OR ACTION. THE DEVICE WAS TRIED WITH ANOTHER BATTERY AND STILL FAILED TO START. BOTH BATTERIES WERE CHECKED WITH ANOTHER HANDPIECE TO CONFIRM THEY WERE CHARGED. THERE WAS NO REPORT OF SURGICAL DELAY OR PATIENT HARM AND SURGERY WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297126 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T UNIVERSAL MODULAR ELECTRIC/BATTERY DOU GFA ZIMMER SURGICAL S.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1