BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS SUTURE PASSER

    MDR report key: 3970717 · Received June 2, 2014

    Report

    Report Number
    3006524618-2014-00166
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A FIRSTPASS SUTURE PASSER, THE DEVICE WAS NOT FUNCTIONING PROPERLY. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320945 FIRSTPASS SUTURE PASSER SUTURE UNITS GAT ARTHROCARE CORPORATION 21969

    Patients

    Seq Age Sex Outcome Treatment
    1