BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER

    MDR report key: 10733266 · Received October 23, 2020

    Report

    Report Number
    MW5097441
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    October 21, 2020
    Manufacturer
    SYNERGETICS INC.
    Product Code
    GZX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF TANO SCRAPPER NOTED TO BE MISSING AFTER USE. EYE AND ROOM EXPLORED, TIP NOT FOUND. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195970 STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER INSTRUMENT, MICROSURGICAL GZX SYNERGETICS INC. M0013988

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR