BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGETICS VISION

    MDR report key: 2935956 · Received January 28, 2013

    Report

    Report Number
    2935956
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    September 14, 2012
    Report Date
    January 28, 2013
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE STAFF MEMBER TRIED TO ENGAGE THE LASER, THERE WAS NO AIMING BEAM AND AFTER FURTHER INSPECTION IT WAS DISCOVERED THAT THE CORD WAS BROKEN FROM THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38110 SYNERGETICS VISION LASER, OPHTHALMIC GEX SYNERGETICS, INC. * M075450

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR