BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER MULTIVAC 50 ICW

    MDR report key: 2822960 · Received October 23, 2012

    Report

    Report Number
    3006524618-2012-00832
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MANUFACTURER NARRATIVE: THE PT IDENTIFIER, AGE, WEIGHT AND GENDER WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PART OF THE METAL TIP BROKE AWAY INTO THE PT'S KNEE. THE REPORT DOES NOT INDICATE THAT THE DETACHED TIP WAS LEFT IN THE PT'S SURGICAL SITE. THERE WERE NO OTHER COMPLICATIONS REPORTED. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER MULTIVAC 50 ICW ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION E916620-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention