BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ URETERAL STENT

    MDR report key: 1081166 · Received July 23, 2008

    Report

    Report Number
    MW5007777
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 23, 2008
    Manufacturer
    KARL STORZ ENDOSCOPY AMERICA
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STORZ LIGHTED URETERAL STENT PACKAGE INSERT CONTAINING STERILIZATION DIRECTIONS AND INDICATIONS FOR USE INFO WAS FOR A PRODUCT DIFFERENT THAN THE DEVICE IN PACKAGE. THIS WAS DISCOVERED BEFORE PT INVOLVEMENT. MANUFACTURER CONTACTED FOR DIRECTIONS AND ULTIMATELY DEVICE WAS ABLE TO BE USED AND WE PROCEEDED WITH SURGERY. ISSUE IS INCORRECT LABELING AND DIRECTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ URETERAL STENT LIGHTED URETERAL PROBE FAD KARL STORZ ENDOSCOPY AMERICA LIGHTED URETERAL

    Patients

    Seq Age Sex Outcome Treatment
    1