BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CASSETTE FOR SPEEDSTICH

    MDR report key: 2485329 · Received February 22, 2012

    Report

    Report Number
    3006524618-2012-00315
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 25, 2012
    Manufacturer
    ARTHROCARE CORP
    Product Code
    GAT
    PMA / PMN Number
    K042031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT¿S AGE AND GENDER HAVE BEEN REQUESTED BUT WERE NOT RECEIVED. THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, THEREFORE NO DEVICE MFR DATE OR EXPIRATION DATE COULD BE DETERMINED. REFERENCE MFR REPORT(S): 9019871-2012-0031, 901987-2012-00317.

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC PROCEDURE, THE PHYSICIAN WAS REPORTEDLY UTILIZING A SPEEDSTITCH SUTURING DEVICE AND CARTRIDGE. WHILE ENGAGING THE NEEDLE AND PLACING THE SUTURE, THE SUTURE CARTRIDGE POPPED OUT OF HANDLE, NEARLY LANDING IN THE SURGICAL SITE. A SECOND CARTRIDGE WAS LOADED; HOWEVER, THE PHYSICIAN WAS UNABLE TO SECURE THE CARTRIDGE IN THE HANDLE. THE PROCEDURE WAS COMPLETED USING A COMPETITOR¿S SUTURE. NO PT INJURY OR OTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE CASSETTE FOR SPEEDSTICH SUTURE DEVICE, ENDOSCOPIC ACCESSORY GAT ARTHROCARE CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention