BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYLOOP

    MDR report key: 3940402 · Received July 7, 2014

    Report

    Report Number
    3940402
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 7, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOUND PRIOR TO USE - OLYMPUS POLYLOOP DEFECTIVE OUT OF THE PACKAGE. NO FURTHER DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394692 POLYLOOP LIGATOR MND OLYMPUS MEDICAL SYSTEMS CORPORATION HX-400U-30 2K7013

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR