BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX AR-9704-90

    MDR report key: 1527131 · Received November 11, 2009

    Report

    Report Number
    MW5013466
    Event Type
    Injury
    Date Received
    November 11, 2009
    Date of Event
    July 23, 2009
    Report Date
    November 10, 2009
    Manufacturer
    MEDISISS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LEFT SHOULDER ARTHROSCOPY, THE OPES WAND WAS IN USE. THE SURGEON NOTICED A SMALL METAL RING WAS DISLODGED FROM THE WAND AND INSIDE THE SHOULDER. THE RING WAS REMOVED AND THE OPES WAND WAS REMOVED FROM THE SERVICE. DATE OF USE: 2009. DIAGNOSIS OR REASON FOR USE: LEFT SHOULDER IMPINGEMENT SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX AR-9704-90 OPES ABLATOR, 90 DEGREE, LOW PROFILE GEI MEDISISS 36927

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention