BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT HIPVAC 50 WAND WITH INTEGRATED FINGER

    MDR report key: 2980325 · Received February 22, 2013

    Report

    Report Number
    3006524618-2013-00079
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE USING THE AMBIENT HIPVAC 50 WAND, THE DISTAL TIP DETACHED FROM THE WAND. THE PROCEDURE WAS DELAYED FOR ONE HOUR WHILE THE TIP WAS RETRIEVED, BUT ULTIMATELY THE PROCEDURE WAS COMPLETED WITH A BACK UP WAND WITHOUT FURTHER REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77334 AMBIENT HIPVAC 50 WAND WITH INTEGRATED FINGER ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION 4319320-A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other