BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4972889 · Received August 3, 2015

    Report

    Report Number
    3008788191-2015-00040
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    February 15, 2013
    Report Date
    February 20, 2013
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    HALF OF CONNECTORS ARE NOT ENGAGED DURING THE TIGERPAW SYSTEM II DEVICE USE. IT'S ASSUMED THAT ONE OR MORE SUTURES WERE USED TO COMPLETE THE PROCEDURE. THERE IS NO PT EFFECT. THERE IS NO BLOOD LOSS AS A RESULT OF THE REPORTED ISSUE. THERE IS NO DELAY IN PROCEDURE. THE TIGERPAW SYSTEM II DEVICES WERE USED DURING CARDIOPULMONARY BYPASS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505937 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07 0633M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention