BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1445025 · Received August 11, 2009

    Report

    Report Number
    9610617-2009-00025
    Event Type
    Other
    Date Received
    August 11, 2009
    Date of Event
    June 24, 2009
    Report Date
    August 10, 2009
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: ALL RETURNED ITEMS TESTED: (B)(4)/DISSECTING CANNULA, (B)(4)/MONOPOLAR CABLE, (B)(4)/MODULAR HANDLE W/ TRUMPET VALVE, (B)(4)/MODULAR HANDLE W/O VALVE. THE DEVICES WERE CONNECTED TO THE AUTOCON II 400 ELECTROSURGICAL UNIT AS THE HIGH FREQUENCY POWER SOURCE. THE COMBINATION OF CANNULA, CORD, TRUMPET VALVE, AND HANDLE WERE TESTED AND WERE IN WORKING CONDITION. HOWEVER, WE COULD NOT DUPLICATE THE PROBLEM.

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING A LAP CHOLE PROCEDURE WHILE OPERATING THE FOOT PEDAL TO CAUTERIZE TISSUE, THE HEAT FROM THE TRUMPET VALVE HANDLE ALLEGEDLY BURNED A HOLE IN HIS GLOVE. DOCTOR SUSTAINED A MINOR BURN ON HIS RIGHT HAND IN THE PERIMETER AREA BETWEEN HIS THUMB AND POINTER FINGER. NO MEDICAL TREATMENT WAS NECESSARY. PROCEDURE WAS COMPLETED WITH NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ MODULAR HANDLE W/ TRUMPET VALVE HET KARL STORZ GMBH & CO. KG 30804 CA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other