BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT HIPVAC 50

    MDR report key: 2852665 · Received November 14, 2012

    Report

    Report Number
    3006524618-2012-00890
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ARTHROCARE CORP
    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

    THE PT IDENTIFIER, AGE, WEIGHT AND GENDER WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SEVERAL ELECTRODES CAME OFF THE WAND. ALL PIECES WERE RETRIEVED FROM THE SURGICAL SITE. THE PROCEDURE CONTINUED WITHOUT FURTHER CONSEQUENCES AND WAS COMPLETED USING COMPETITOR'S PRODUCT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIENT HIPVAC 50 ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other