BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSHER MALYUGIN RING MANIPULATOR

    MDR report key: 20071540 · Received August 26, 2024

    Report

    Report Number
    3019924-2024-00011
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 26, 2024
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC.
    Product Code
    HNQ
    UDI-DI
    00844685003747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DURING CATARACT SURGERY THE BALL ON OSHER MALYUGIN MANIPULATOR BROKE OFF IN THE MALYUYGIN RING WHEN THE PHYSICIAN WAS MANIPULATING THE RING IN THE EYE. THE DOCTOR WAS ABLE TO REMOVE THE BALL FROM THE PATIENT'S EYE WITHOUT INJURING THE PATIENT. THE PATIENT IS DOING WELL, AND A SUCCESSFUL SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19337 OSHER MALYUGIN RING MANIPULATOR OPHTHALMIC HOOK HNQ MICROSURGICAL TECHNOLOGY INC. MAL-0003 00844685003747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other