BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ ENDOSCOPY LARYNGOSCOPE BLADE

    MDR report key: 5267629 · Received December 1, 2015

    Report

    Report Number
    MW5058314
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    November 26, 2015
    Report Date
    December 1, 2015
    Manufacturer
    AMERICA INC.
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    HANDLE LEFT FLICKERED ON LARYNGOSCOPE BLADE REQUIRING APPLICATION OF ADDITIONAL TORQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790306 KARL STORZ ENDOSCOPY LARYNGOSCOPE BLADE LARYNGOSCOPE BLADE CAL AMERICA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization