BEUDAMED
    FDA Adverse Event Other Summary report: N

    STORZ HI FREQUENCY CORD

    MDR report key: 343712 · Received July 23, 2001

    Report

    Report Number
    MW1022461
    Event Type
    Other
    Date Received
    July 23, 2001
    Date of Event
    July 3, 2001
    Report Date
    July 23, 2001
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC
    Product Code
    KNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR SURGICAL CASE IN THE OPERATING ROOM, A STAFF NURSE WAS SETTING UP THE MONOPOLAR CAUTERY UNIT. THE NURSE WAS MANIPULATING THE STORZ HI FREQUENCY CORD ATTACHED TO THE UNIT AS A RESULT OF A MALFUNCTION. THE CORD ABRUPTLY SNAPPED, CAUSING FLAME AND AN ELECTRIC SHOCK TO THE NURSE. THE NURSE SUFFERED A 1ST DEGREE BURN TO ONE FINGER. PRIOR TO THE EVENT, THE CORD AND EQUIPMENT HAD BEEN INSPECTED AND APPEARED INTACT, WITHOUT ANY SIGNS OF WEAR OR STRESS. THE CORD IS ROUTINELY STERILIZED IN ACCORDANCE WITH MFR'S RECOMMENDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33236 STORZ HI FREQUENCY CORD POWER CORD FOR MONOPOLAR CAUTERY UNIT KNS KARL STORZ ENDOSCOPY-AMERICA, INC 26006M *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other