BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTRELEASE ECTR

    MDR report key: 3126607 · Received April 5, 2013

    Report

    Report Number
    3126607
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS LLC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    ENDOSCOPIC CARPAL TUNNEL BLADE MALFUNCTION - BLADE WOULD NOT RETRACT WITH CAMERA IN PLACE.DISPOSABLE BLADE WOULD NOT RETRACT WHILE THE SCOPE WAS ATTACHED. TRADED BLADES OUT AND CONTINUED WITH THE CASE. PUT BLADE BACK IN ORIGINAL PACKAGING, IN A BIO BAG AND GAVE TO THE CORE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CARPAL TUNNEL RELEASE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142320 SMARTRELEASE ECTR ARTHROSCOPE HRX MICROAIRE SURGICAL INSTRUMENTS LLC * 0512203184

    Patients

    Seq Age Sex Outcome Treatment
    1 *