BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1060545 · Received June 12, 2008

    Report

    Report Number
    1056128-2008-00046
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    HRX
    PMA / PMN Number
    K012346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE USED DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE SIGNS OF ABRASION AND GALLING ON THE OUTER SHAFT. INSPECTION OF THE INNER SHAFT REVEALED GALLING MARKS ALONG THE SHAFT AND A VISIBLE GOUGE ON THE INNER SHAFT. IT HAS BEEN CONCLUDED THAT THE CAUSE FOR SHAVING GENERATION WAS THE EXCESSIVE EXERTION OF LATERAL FORCES (SIDE LOADING) ON ARTHROSCOPIC SHAVER INSTRUMENTS DURING CLINICAL USE. ASCENT HEALTHCARE SOLUTIONS' IFU STATES: DO NOT APPLY EXCESSIVE PRESSURE OR SIDE-LOAD THE BLADE DURING USE. SIDE-LOADING DOES NOT IMPROVE THE 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 WERE FOUND, INDICATING THE DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS AND WAS FUNCTIONING PROPERLY PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ARTHROSCOPIC SHAVER WAS EMITTING METAL SHAVINGS IN THE SURGICAL SITE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA HRX ASCENT HEALTHCARE SOLUTIONS 7206010 154588

    Patients

    Seq Age Sex Outcome Treatment
    1