BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ ENDOSCOPY-AMERICA, INC STORZ SHEATH

    MDR report key: 1013925 · Received March 12, 2008

    Report

    Report Number
    MW5005886
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 12, 2008
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STORZ SHEATH #27040 WAS USED IN THE OR FOR A HYSTEROSCOPY WITH DILATATION AND CURETTAGE. AFTER THE SURGERY WAS COMPLETED, THE CERAMIC TIP AT THE DISTAL END OF THE SHEATH WAS MISSING. PT WAS RETURNED TO OR FOR A DIAGNOSTIC HYSTEROSCOPY, BUT DID NOT FIND ANY FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ ENDOSCOPY-AMERICA, INC STORZ SHEATH STORZ SHEATH FJL KARL STORZ ENDOSCOPY-AMERICA, INC 27040 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention