BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T

    MDR report key: 3202187 · Received June 28, 2013

    Report

    Report Number
    8031000-2013-00105
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE WAS INTERMITTENT AND DID NOT WORK. THERE WAS NO REPORT OF SURGICAL DELAY OR PATIENT INJURY ASSOCIATED WITH THE EVENT. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296127 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