BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPES ASPIRATING ABLATOR, 3MM, 90 DEGREE, LOW PROFILE

    MDR report key: 1102168 · Received August 7, 2008

    Report

    Report Number
    1220246-2008-00152
    Event Type
    Other
    Date Received
    August 7, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    GEI
    PMA / PMN Number
    K023986
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THE COATING ON THE DISTAL END OF THE INSTRUMENT HAD SCRATCHES AND GOUGES IN IT. THE BLUE COATING IS AN INSULATIVE NON-METALLIC TGIC POLYESTER POWER COAT. THE EVENT DESCRIPTION OF "SHAVINGS" COMING OFF THE DISTAL END OF THE WAND TYPICALLY IS CAUSED BY MECHANICAL DAMAGE RELATED TO DEVICE HANDING, SUCH AS THE DEVICE HITTING AGAINST ANOTHER DEVICE. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE EVENT WAS ATTRIBUTED TO MISUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLUE METAL SHAVINGS CAME OFF THE DISTAL END OF THE WAND DURING A WRIST SCOPE PROCEDURE. THE SHAVINGS WERE NOT RETRIEVED. FOLLOW-UP INFO WAS PROVIDED THAT THE PATIENT IS FINE AND NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPES ASPIRATING ABLATOR, 3MM, 90 DEGREE, LOW PROFILE GEI ARTHREX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other