BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1882023 · Received October 25, 2010

    Report

    Report Number
    1056128-2010-00077
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ASCENT
    Product Code
    HRX
    PMA / PMN Number
    K012611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED GALLING MARKS ON THE DISTAL END OF THE INNER SHAFT AND METAL PARTICULATES ON THE RUBBER SEAL COMPONENT OF THE OUTER SHAFT HUB. THE GALLING MARKS ON THE DEVICE INDICATE EXCESSIVE LATERAL OR "SIDE LOADING" OF THE DEVICE. THIS CAN CAUSE DAMAGE TO THE DEVICE AND THE EMISSION OF METAL SHAVINGS CAN OCCUR. ASCENT'S INSTRUCTIONS FOR USE STATES: "DO NOT APPLY EXCESSIVE PRESSURE OR "SIDE-LOAD" THE BLADE DURING USE. SIDE-LOADING DOES NOT IMPROVE PERFORMANCE OF THE INSTRUMENT, CAN DULL THE BLADE, AND/OR PRODUCE METAL PARTICULATES." THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE SHAVER PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AN ARTHROSCOPIC SHAVER PRODUCED METAL SHAVINGS. THE PROCEDURE TIME WAS EXTENDED 20 TO 30 MINUTES AND THE PATIENT WAS ADMINISTERED ADDITIONAL ANESTHESIA. IT WAS REPORTED THAT IT "TOOK A LOT OF IRRIGATION TO REMOVE" THE SHAVINGS. ALL VISIBLE SHAVINGS WERE REMOVED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A HRX HRX ASCENT 7205305 756866

    Patients

    Seq Age Sex Outcome Treatment
    1