BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS SUTURE PASSER

    MDR report key: 3791814 · Received January 21, 2014

    Report

    Report Number
    3006524618-2014-00025
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 18, 2013
    Report Date
    December 20, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GAT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A FIRSTPASS SUTURE PASSER, THE HANDLE ON THE DEVICE BROKE OFF. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50836 FIRSTPASS SUTURE PASSER SUTURE UNITS GAT ARTHROCARE CORPORATION 7459

    Patients

    Seq Age Sex Outcome Treatment
    1 Other