BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS ARMATEC MICROSCOPE DRAPE FOR LEICA

    MDR report key: 7869005 · Received September 11, 2018

    Report

    Report Number
    MW5079731
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    August 8, 2018
    Report Date
    September 5, 2018
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEURO MICROSCOPE. LENS, EYEPIECES AND LIGHT CLEAR AND FUNCTIONAL BEFORE SCOPE DRAPED WITH STERILE DRAPE FOR PROCEDURE. SCOPE DRAPED WITH "GENESYS MICROSCOPE DRAPE." AFTER DRAPE WITH LENS ATTACHED TO DRAPE IN PLACE, SURGICAL FIELD WAS CLOUDY. IT WAS LIKE LOOKING THROUGH FOG. DRAPE CHANGED AND NEW DRAPE APPLIED WITH SAME RESULT. COULD NOT GET A CLEAR SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706977 GENESYS ARMATEC MICROSCOPE DRAPE FOR LEICA DRAPE, SURGICAL KKX MICROTEK MEDICAL INC. AR8033650 D181192

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention