BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2802501 · Received September 24, 2012

    Report

    Report Number
    2802501
    Event Type
    Malfunction
    Date Received
    September 24, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 24, 2012
    Manufacturer
    KARL STORZ ENDOSCOPY
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER THE PROCEDURE, THE SCOPE AND INNER SHEATH WERE REMOVED FROM THE PATIENT. THE CERAMIC TIP OF INNER SHEATH WAS NOTICED TO HAVE A PIECE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED KARL STORZ ENDOSCOPY 27040XB/XD 0123LOTGG

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR