BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G INVERTED EXTENDABLE DIRECTIONAL LASER PROBE

    MDR report key: 1260524 · Received December 3, 2008

    Report

    Report Number
    1260524
    Event Type
    Malfunction
    Date Received
    December 3, 2008
    Date of Event
    November 20, 2008
    Report Date
    December 3, 2008
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER PROBE TIP BROKE OFF IN PATIENT'S EYE. IT WAS RETRIEVED AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 23G INVERTED EXTENDABLE DIRECTIONAL LASER PROBE LASER PROBE, OPHTHALMIC GEX SYNERGETICS, INC. * 7020135

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR