BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER TURBOVAC 90 WITH IFS

    MDR report key: 2802467 · Received October 18, 2012

    Report

    Report Number
    3006524618-2012-00825
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A PT IDENTIFIER, AGE, WEIGHT AND GENDER WERE NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE THE METAL SCREEN FELL OFF THE WAND. THE DOCTOR WAS SCOPING AFTER A TOTAL KNEE AND HIT THE WAND ON A PIECE OF METAL; POSSIBLY THE SCOPE. RIGHT AFTER HE HIT IT THE TIP FELL OFF INTO THE KNEE. THE PIECE WAS RETRIEVED WITH A GRASPER AND THE CASE WAS SUCCESSFULLY COMPLETED. NO PT INJURIES OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIENT SUPER TURBOVAC 90 WITH IFS ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION 0108820-B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention