BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS SUTURE PASSER

    MDR report key: 2950541 · Received February 5, 2013

    Report

    Report Number
    3006524618-2013-00058
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GCJ
    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 SHOULDER REPAIR PROCEDURE USING THE FIRSTPASS SUTURE PASSER, THE SUTURE TRAP FELL OFF WHILE INSIDE THE PT. THE SURGEON WAS CONFIDENT THAT THE PIECE WAS REMOVED VIA SUCTION, BUT COULD NOT BE POSITIVE. THE INTRAOPERATIVE X-RAY WAS NEGATIVE FOR ANY DEBRIS REMAINING IN THE PT, AND THE PROCEDURE WAS COMPLETED USING A BACK UP FIRSTPASS SUTURE PASSER. 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
    49026 FIRSTPASS SUTURE PASSER SUTURE UNITS GCJ ARTHROCARE CORPORATION 13318

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other