BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOLF MONOPOLAR CORD

    MDR report key: 284732 · Received July 5, 2000

    Report

    Report Number
    MW1019241
    Event Type
    Injury
    Date Received
    July 5, 2000
    Date of Event
    June 29, 2000
    Report Date
    July 5, 2000
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    KNF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN THE O.R. UNDERGOING REMOVAL OF GALLBLADDER. A VALLEYLAB BOVIE ESU UNIT WITH A WOLF MONOPOLAR CORD WAS USED FOR CAUTERIZATION. AT FIRST ATTEMPT UNIT APPEARED TO NOT WORK, POWER WAS INCREASED FROM 35 TO 40, FLAMES WERE NOTED ON CORD APPROXIMATELY ONE INCH FROM CONNECTION. UNIT WAS REMOVED, TURNED OFF. REPLACEMENT UNIT AND CORD WERE USED. NO BURNS TO PT OR SURROUNDING DRAPES. REMAINDER OF CASE WAS UNEVENTFUL. WOLF MONOPOLAR CORD # 8106.034 OR 9, NUMBER DIFFICULT TO MAKE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOLF MONOPOLAR CORD LEAD/CORD FOR CONNECTION TO VALLEY LAB BOVIE KNF RICHARD WOLF MEDICAL INSTRUMENTS CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening