BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST OSHER MALYUGIN MANIPULATOR

    MDR report key: 3928362 · Received June 19, 2014

    Report

    Report Number
    3019924-2014-00020
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND AN EVAL TO DETERMINE THE CAUSE OF THE BREAKAGE WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE MST OSHER MALYUGIN MANIPULATOR BROKE WHEN THE SURGEON ATTEMPTED TO USE IT TO REMOVE A MALYUGIN RING. THERE WAS NO IMPACT TO THE PT AND THE BROKEN PIECE WAS REMOVED FROM THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359586 MST OSHER MALYUGIN MANIPULATOR OPHTHALMIC HOOK HMX MICROSURGICAL TECHNOLOGY, INC. MAL-0003

    Patients

    Seq Age Sex Outcome Treatment
    1