BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSTITCH SUTURING DEVICE

    MDR report key: 3240993 · Received July 17, 2013

    Report

    Report Number
    3006524618-2013-00288
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GAT
    PMA / PMN Number
    K042031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY STABILIZATION PROCEDURE USING A SPEEDSTITCH SUTURING DEVICE, THE DEVICE NEEDLE FIRED PROPERLY, HOWEVER IT WOULD NOT PICK UP THE SUTURE. A NEW NEEDLE AND SUTURE WERE OPENED AND TRIED WITH THIS DEVICE, BUT WITH THE SAME RESULT. THIS EVENT CAUSED A SURGICAL DELAY OF 30 MINUTES AND ULTIMATELY THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITH A COMPETITOR'S DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333051 SPEEDSTITCH SUTURING DEVICE SUTURE UNITS GAT ARTHROCARE CORPORATION H913900R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other