BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 110018 · Received July 31, 1997

    Report

    Report Number
    MW1011803
    Event Type
    Malfunction
    Date Received
    July 31, 1997
    Date of Event
    July 23, 1997
    Report Date
    July 31, 1997
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS BURRING THE TIBIA WITH A 4.0 MM ROUND BUR. METAL SHAVINGS WERE NOTED IN THE OPERATIVE AREA. THE INSTRUMENT WAS IMMEDIATELY REMOVED. THE METAL SHAVINGS WERE EVACUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY 4.0 MM RAND BUR HRX STRYKER ENDOSCOPY 275-841-000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other