BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBOWHISKER BLADE EP-1; 4.5MM

    MDR report key: 1635645 · Received March 10, 2010

    Report

    Report Number
    1219602-2010-00044
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    March 17, 2009
    Report Date
    March 19, 2009
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CLEANING SOLUTION HAS BEEN IMPLEMENTED DURING THE METAL FINISHING PREP STEP. THIS HAS ELIMINATED ANY EDM RESIDUE, PRIOR TO ASSEMBLY. (B) (4).

    Description of Event or Problem · 1

    STARTED CASE AND DOCTOR NOTICED AN OILY SUBSTANCE COMING OUT OF BLADE, OPENED ANOTHER SAME LOT NUMBER AND SAME ISSUE. WENT TO ANOTHER TYPE OF BLADE AND WAS ABLE TO FINISH CASE. FLUSHED OUT OILY SUBSTANCE. METAL SHAVING ALSO AT THE BEGINNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOWHISKER BLADE EP-1; 4.5MM TURBOWHISKER BLADE EP-1; 4.5MM / NBH NBH MANSFIELD MANUFACTURING SITE 7205316 20126463

    Patients

    Seq Age Sex Outcome Treatment
    1