BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1027742 · Received March 22, 2008

    Report

    Report Number
    2020550-2008-00007
    Event Type
    Other
    Date Received
    March 22, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 20, 2008
    Manufacturer
    KARL STORZ IMAGING
    Product Code
    FWG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT CONTROL BUTTON ON CAMERA CAME OFF INTO THE STERILE FIELD DURING PROCEDURE. OR PERSONNEL REPORT THAT THEY SPENT 1 HR SEARCHING FOR THE BUTTON. THEY FOUND THE BUTTON IN THE FOLDS OF THE PT DRAPE. PROCEDURE WAS COMPLETED WITH NO IMPACT OTHER THAN DELAY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ HD IMAGE 1 CAMERA FWG KARL STORZ IMAGING 22220150-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other