BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCOPE / LASER DRAPE

    MDR report key: 16426456 · Received February 23, 2023

    Report

    Report Number
    16426456
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    February 9, 2023
    Report Date
    February 9, 2023
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE PROTECTIVE PLASTIC PIECE WHICH COVERS THE LENS OF THE MICROSCOPE WAS DISCOVERED LOOSE IN THE MICROSCOPE DRAPE. THE LENS OF THE MICROSCOPE WAS UNCOVERED FACING THE PATIENT. MD WAS MADE AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444196 MICROSCOPE / LASER DRAPE DRAPE, SURGICAL, EXEMPT PUI MICROTEK MEDICAL INC. AR8033650 5392LRO500

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA Female