BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T

    MDR report key: 4810989 · Received May 29, 2015

    Report

    Report Number
    8031000-2015-00069
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    April 1, 2015
    Report Date
    May 26, 2015
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE DOESN'T STOP WHEN THE USER RELEASED THE TRIGGER. THERE WAS NOT PATIENT HARM REPORTED. THE TIME SURGERY WAS EXTENDED LESS OF 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348011 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T GFA ZIMMER SURGICAL S.A. NA 5003835

    Patients

    Seq Age Sex Outcome Treatment
    1