BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 3111636 · Received May 7, 2013

    Report

    Report Number
    MW5030126
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 7, 2013
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    KARL STORZ INSUFFLATOR MALFUNCTIONED; TANKS WERE FILLED, GAS WAS GOING TO THE MACHINE, THE MACHINE LIT UP THREE GREEN BARS, BUT NO GAS WAS COMING OUT OF THE PT CONNECTOR-CONFIRMED NO GAS FLOW OUT OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197693 KARL STORZ INSUFFLATOR HIF KARL STORZ ENDOSCOPY-AMERICA, INC. ASC VIDEO TOWER 1

    Patients

    Seq Age Sex Outcome Treatment
    1 *