BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 13938150 · Received March 29, 2022

    Report

    Report Number
    8043817-2022-00004
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 29, 2022
    Manufacturer
    ECOLAB/MICROTEK MEDICAL INC.
    Product Code
    PUI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LENS COVER OF THE MICROSCOPE DRAPE WAS CRACKED. THERE WERE NO REPORTED PROBLEMS DURING THE OPERATION AND NO PATIENT INJURY, INFECTION, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760760 OLYMPUS MICROSCOPE DRAPE PUI ECOLAB/MICROTEK MEDICAL INC. OME-V2-D NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown