BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 5000457 · Received August 4, 2015

    Report

    Report Number
    3008788191-2015-00093
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 30, 2014
    Report Date
    August 5, 2014
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    A 2ND TIGERPAW SYSTEM II DEVICE WAS USED TO SECURE LEFT ATRIAL APPENDAGE (MOST LIKELY THE FIRST TIGERPAW SYSTEM II DEVICE WAS MISFIRED). THERE WAS NO BLEEDING BASED ON THIS EVENT. . THERE WERE NO PATIENT NEGATIVE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510224 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC

    Patients

    Seq Age Sex Outcome Treatment
    1