BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMATEC MICTROSCOPE DRAPE FOR LEICA

    MDR report key: 17004264 · Received May 24, 2023

    Report

    Report Number
    MW5117856
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    May 16, 2023
    Report Date
    May 22, 2023
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MICROSCOPE DRAPE WAS OPENED TO THE FIELD. AS SCRUB TECH WAS PICKING UP SUPPLIES AND ORGANIZING SHE FOUND A HAIR STUCK INSIDE THE MICROSCOPE DRAPE. THIS WAS IMMEDIATELY REMOVED AND OPERATING ROOM TEAM BROKE DOWN THE STERILE FIELD BECAUSE OF POSSIBLE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575701 ARMATEC MICTROSCOPE DRAPE FOR LEICA DRAPE, SURGICAL KKX MICROTEK MEDICAL INC. AR8033650 1442LR1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown