BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1243184 · Received November 10, 2008

    Report

    Report Number
    1056128-2008-00085
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 14, 2008
    Report Date
    November 10, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    HRX
    PMA / PMN Number
    K012611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED GALLING MARKS ALONG THE SHAFT. THE OBSERVED GALLING MARKS INDICATE THAT EXCESSIVE "SIDE-LOADING" FORCE WAS EXERTED ONTO THE DEVICE WHILE IN USE, THUS CAUSING DISCHARGE OF METAL FRAGMENTS. ASCENT HEALTHCARE SOLUTIONS' IFU STATES: "DO NOT APPLY EXCESSIVE PRESSURE OF SIDE-LOAD THE BLADE DURING USE. SIDE-LOADING DOES NOT IMPROVE PERFORMANCE OF THE INSTRUMENT, CAN DULL THE BLADE, AND/OR PRODUCT 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

    THE DEVICE EMITTED METAL SHAVINGS DURING THE PROCEDURE. NO SHAVINGS WERE LEFT IN THE PATIENT; AND THERE WAS NO ADVERSE OUTCOME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA HRX ASCENT HEALTHCARE SOLUTIONS C9254 171191

    Patients

    Seq Age Sex Outcome Treatment
    1