BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK CLIP 2

    MDR report key: 1871399 · Received September 29, 2010

    Report

    Report Number
    1871399
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    OLYMPUS AMERICA INC
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    THE CLIP DID NOT DEPLOY FROM THE SHEATH. IT IS UNKNOWN HOW THE EVENT OCCURRED. THE DEVICE DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK CLIP 2 CLIP FIXING DEVICE MND OLYMPUS AMERICA INC HX-201UR-135 0K6110

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR