BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROCARE FOOT CONTROL

    MDR report key: 2741676 · Received August 31, 2012

    Report

    Report Number
    3006524618-2012-00760
    Event Type
    Malfunction
    Date Received
    August 31, 2012
    Report Date
    August 2, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K032504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S AG AND GENDER HAVE BEEN REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE FOOT CONTROL WORKED INTERMITTENTLY. SURGEON WAS REQUIRED TO COMPLETE PROCEDURE BY USING A ELECTROCAUTERY UNIT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROCARE FOOT CONTROL ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION 105224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other