BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 697550 · Received March 28, 2006

    Report

    Report Number
    2020550-2006-00017
    Event Type
    Other
    Date Received
    March 28, 2006
    Date of Event
    February 17, 2005
    Report Date
    March 24, 2005
    Manufacturer
    D & R PRODUCTS CO., INC.
    Product Code
    HTT
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SHOULDER ARTHROSCOPY USING A KARL STORZ SHAVER BURR THE CUSTOMER NOTICED SHINY PARTICLES, WHICH THEY BELIEVED WERE METAL, COMING FROM THE SHAVER BURR. THEY STOPPED USING THE BURR, IRRIGATED THE AREA AND BELIEVE THEY WERE ABLE TO FLUSH OUR APPROXIMATELY 95% OF THE METAL PARTICLES. THE PROCEDURE WAS COMPLETED USING A NEW SHAVER BURR AND NO OTHER PARTICLES WERE NOTED. PATIENT CONDITION POST-OP WAS STABLE AND NO FURTHER SURGERY WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ POWERSHAVER DISPOSABLE BURR HTT D & R PRODUCTS CO., INC. 28205FDS 16747

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other