BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3853970 · Received April 17, 2014

    Report

    Report Number
    8031000-2014-00220
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OT THIS 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 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE WAS BLOCKED AND NOT FUNCTIONAL. THERE WAS NO PT HARM; HOWEVER THERE WAS A DELAY IN SURGERY FOR APPROXIMATELY 1.5 HRS. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236007 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIV MODULAR ELECTRIC/BATTERY DOUBLE GEY ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1