BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS SUTURE PASSER

    MDR report key: 3021026 · Received March 20, 2013

    Report

    Report Number
    3006524618-2013-00115
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE USING THE FIRSTPASS SUTURE PASSER, WHEN THE NEEDLE WAS LOADED IT KEPT JAMMING IN THE HANDLE OF THE GUN. THE SURGEON CHOSE TO COMPLETE THE PROCEDURE WITH A COMPETITOR'S PRODUCT. THERE WERE NO OTHER DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116261 FIRSTPASS SUTURE PASSER SUTURE UNITS GAT ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other