BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS SUTURE PASSER

    MDR report key: 2872459 · Received December 11, 2012

    Report

    Report Number
    3006524618-2012-00953
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BANKART REPAIR PROCEDURE USING THE FIRSTPASS SUTURE PASSER, THE DEVICE WAS STICKING AND NOT RELEASING PROPERLY. THE PROCEDURE WAS ULTIMATELY COMPLETED WITH AN ARTHREX SUTURE CUTTER. 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
    1 FIRSTPASS SUTURE PASSER SUTURE UNITS GCJ ARTHROCARE CORPORATION 11974

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other