BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 5045299 · Received August 28, 2015

    Report

    Report Number
    3008788191-2015-00120
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    January 26, 2015
    Report Date
    January 28, 2015
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    NOT ALL CONNECTORS OF THE TIGERPAW SYSTEM II DEVICE WERE ENGAGED. THE LEFT ATRIUM APPENDAGE WAS OVER-SEWED W/SUTURE. THERE WAS NO PATIENT NEGATIVE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572811 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR