BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ

    MDR report key: 585937 · Received March 17, 2005

    Report

    Report Number
    585937
    Event Type
    Malfunction
    Date Received
    March 17, 2005
    Date of Event
    February 2, 2005
    Report Date
    February 9, 2005
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FBJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE ESU DURING A CASE, THE CORD BETWEEN THE RESECTOSCOPE AND ESU BROKE AND SPARKED AT THE RESECTOSCOPE CONNECTOR SIDE OF THE CABLE. THEY REPLACED THE CABLE AND CONTINUED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ CABLE FBJ KARL STORZ ENDOSCOPY-AMERICA, INC. 277 KB FG01

    Patients

    Seq Age Sex Outcome Treatment
    1 *