BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 493841 · Received October 28, 2003

    Report

    Report Number
    2020550-2003-00023
    Event Type
    Malfunction
    Date Received
    October 28, 2003
    Date of Event
    August 25, 2003
    Report Date
    October 24, 2003
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FBJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A HYSTEROSCOPY ENDOMETRIAL ABLATION PROCEDURE, A KARL STORZ HIGH FREQUENCY CORD ALLEGEDLY ARCED AND SNAPPED OFF AT THE INSTRUMENT END. THE FREE END OF THE CORD SWUNG AGAINST THE PT'S LABIA MAJORA ALLEGEDLY CAUSING 2 X 1-2MM BURNS. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT CORD WITH NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ HIGH FREQUENCY CORD FBJ KARL STORZ GMBH & CO. KG 277KB KI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other