BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPUS SMARTSTITCH SUTURE CARTRIDGE

    MDR report key: 2214016 · Received August 3, 2011

    Report

    Report Number
    2032380-2011-00076
    Event Type
    Other
    Date Received
    August 3, 2011
    Date of Event
    June 24, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K022229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED AS RETURNING FOR INVESTIGATION. TO DATE THE DEVICE HAS NOT BEEN RETURNED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION AND LOT HISTORY REVIEW ARE COMPLETED. THE SEVEN ADDITIONAL DEVICES USED IN THIS SAME PROCEDURE WERE FILED UNDER MDR 2032380-2011-00070, 2032380-2011-00071, 2032380-2011-00072, 2032380-2011-00073, 2032380-2011-00074, 2032380-2011-00075, AND 2032380-2011-00077. REF. ARTHROCARE RMA 10025752.

    Description of Event or Problem · 1

    IT WAS REPORTED TO ARTHROCARE THAT A PT UNDERWENT A SHOULDER ARTHROSCOPY PROCEDURE AND RCR REPAIR USING FOUR OPUS SMARTSTITCH M-CONNECTORS, THREE OPUS SMARTSTITCH SUTURE CARTRIDGES AND ONE OPUS SMARTSTITCH SUTURE DEVICE HANDLE. ALLEGEDLY, THE SMARTSTITCH SUTURE DEVICE HANDLE BROKE THE M-CONNECTORS AND SUTURE CARTRIDGES DURING THE SURGERY. THE PHYSICIAN REVERTED TO A MINI OPEN TO COMPLETE THE SURGERY. THE SURGERY RESULTED IN A 45 MINUTE DELAY. NO ADVERSE REACTIONS TO THE PT AND NO PT INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS SMARTSTITCH SUTURE CARTRIDGE ENDOSCOPE AND ACCESSORIES KOG ARTHROCARE CORPORATION 1009833

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other