BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION TUBING

    MDR report key: 1310713 · Received February 4, 2009

    Report

    Report Number
    1310713
    Event Type
    Malfunction
    Date Received
    February 4, 2009
    Date of Event
    January 29, 2009
    Report Date
    February 4, 2009
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC CONNECTOR BROKE OFF THE INSUFFLATION TUBING USED WITH A 12 FR TROCAR. THE PLASTIC CONNECTOR STAYED CONNECTED TO THE TROCAR. TROCAR AND TIP WERE SAFELY REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FLOW INSUFFLATION TUBING TUBING, INSUFFLATION GCJ KARL STORZ ENDOSCOPY-AMERICA, INC. * 059641

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR