BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3208647 · Received June 19, 2013

    Report

    Report Number
    3208647
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    KARL STORZ ENDOSCOPY
    Product Code
    FXM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING SURGERY FOR A CABG WITH ENDOSCOPIC SAPHENOUS VEIN HARVESTING FROM BOTH LEGS. THE PA WAS USING THE CAMERA AND IT BROKE. THE RINGS OF THE CAMERA BROKE INTO PIECES. ATTEMPTED TO RECREATE THE CAMERA, BUT NOT SURE IF ALL THE PIECES AND SCREWS WERE RETRIEVED. X-RAYS OF BOTH LEGS TAKEN WERE NEGATIVE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VISUALIZATION OF THE SAPHENOUS VEIN FOR HARVESTING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279321 * CAMERA, STILL, ENDOSCOPIC FXM KARL STORZ ENDOSCOPY 22220053 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR