BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1051167 · Received May 20, 2008

    Report

    Report Number
    1056128-2008-00037
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NBH
    PMA / PMN Number
    K012605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED DEVICE WAS RETURNED AND, UPON RECEIPT, IT WAS VISUALLY INSPECTED AND FOUND TO HAVE SIGNS OF ABRASION ON THE OUTER SHAFT. INSPECTION OF THE INNER SHAFT REVEALED GALLING MARKS ON THE INNER SHAFT AND METAL FILINGS INSIDE HUB OF THE INNER SHAFT. IT WAS CONCLUDED THAT THE CAUSE FOR SHAVING GENERATION WAS THE EXCESSIVE EXERTION OF LATERAL FORCES ("SIDE-LOADING") ON ARTHROSCOPIC SHAVER INSTRUMENTS DURING CLINICAL USE. THE INSTRUCTIONS FOR USE STATE: "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 LOT CONTROL SHEET DOCUMENTING THE PROCESSING OF THIS DEVICE WAS REVIEWED AND NO ANOMALIES FOUND, INDICATING THE DEVICE PASSED ALL INSPECTIONS AND TESTS, MEETING ACCEPTANCE CRITERIA PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    DURING SHOULDER SCOPE, SURGEON FELT THAT METAL WAS BEING LEFT FROM INSTRUMENT. IRRIGATION WAS USED TO CLEAR OUT METAL AND NONE WAS RETAINED. NO INJURY TO THE PATIENT OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NBH ASCENT HEALTHCARE SOLUTIONS 375-940-012 145553

    Patients

    Seq Age Sex Outcome Treatment
    1