BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4975948 · Received August 4, 2015

    Report

    Report Number
    3008788191-2015-00052
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    November 27, 2013
    Report Date
    December 2, 2013
    Manufacturer
    LAAX, INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Removal / Correction Number
    Z-1461-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    LEFT ATRIAL APPENDAGE WAS TORN WHEN BARBS OF THE TIGERPAW SYSTEM II DEVICE WERE APPLIED. THE SECOND TIGERPAW SYSTEM II DEVICE WAS SUCCESSFULLY USED TO COMPLETE PROCEDURE. THE SURGEON THINKS THAT USED WRONG JAW LENGTH (9 CONNECTORS INSTEAD OF 7 CONNECTORS) WHY IT WAS NOT FITTED THE APPENDAGE. NO KNOWN PATIENT EFFECT. NO BLOOD LOST REFERRED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509502 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC TP15AJ09

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention