BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3220886 · Received June 27, 2013

    Report

    Report Number
    3220886
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 2, 2013
    Report Date
    June 27, 2013
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC
    Product Code
    FFS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    A THORACOSCOPIC MINI MAZE PROCEDURE WAS BEING PERFORMED USING AN ENDOSCOPIC LIGHT CORD. THE CORD FRACTURED DURING THE PROCEDURE AND CAUSED A BURN TO THE SURGEON'S GOWN. NO INJURY WAS SUSTAINED BY SURGEON OR PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THORACOSCOPIC MINI MAZE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291766 * FIBEROPTIC CABLE, REUSEABLE FFS KARL STORZ ENDOSCOPY-AMERICA, INC ND 495 WZ 05

    Patients

    Seq Age Sex Outcome Treatment
    1 *