BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4992214 · Received August 6, 2015

    Report

    Report Number
    3008788191-2015-00116
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    December 22, 2014
    Report Date
    December 29, 2014
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Removal / Correction Number
    Z-1461-2015/Z-1462-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    SOME CONNECTORS OF THE TIGERPAW SYSTEM II DEVICE WERE NOT ENGAGED. THE TIGERPAW SYSTEM II DEVICE WAS USED DURING MITRAL VALVE PROCEDURE. THERE WERE NO PATIENT NEGATIVE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520214 TIGERPAW SYSTEM II STEPLE, IMPLANTABLE GDW LAAX INC TP15AJ09 1436M

    Patients

    Seq Age Sex Outcome Treatment
    1