BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS SUTURE PASSER

    MDR report key: 5000415 · Received August 5, 2015

    Report

    Report Number
    3006524618-2015-00131
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HWQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 NEEDLE GOT STUCK OUTSIDE OF THE TRACK. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE DEVICE. THERE WAS NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516977 FIRSTPASS SUTURE PASSER SUTURE UNITS HWQ ARTHROCARE CORPORATION 27574

    Patients

    Seq Age Sex Outcome Treatment
    1