BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS NEEDLE AND SUTURE CAPTURE

    MDR report key: 3915473 · Received June 5, 2014

    Report

    Report Number
    3006524618-2014-00161
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A FIRSTPASS NEEDLE AND SUTURE CAPTURE, THE NEEDLE WAS NOT LOADING INTO THE HANDLE PROPERLY. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITOR'S 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
    328859 FIRSTPASS NEEDLE AND SUTURE CAPTURE NEEDLES, SUTURE NBH ARTHROCARE CORPORATION 1030630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other