BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB PENCIL CAUTERY

    MDR report key: 315108 · Received February 6, 2001

    Report

    Report Number
    MW1021023
    Event Type
    Malfunction
    Date Received
    February 6, 2001
    Date of Event
    January 30, 2001
    Report Date
    January 30, 2001
    Manufacturer
    VALLEYLAB INC. PFIZER HOSPITAL PRODUCTS GROUP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT-VALLEYLAB CAUTERY ROCKER W/COATED BLADE. WHILE USING THE ABOVE PRODUCT, WAS KEYING A HEMSTAT. AFTER BUZZING ON THE HEMSTAT FOR A PERIOD OF TIME, THE POINT OF CONTACT WITH THE HEMSTAT AND ELECTRODE FLAMED APPROX 1/4 INCH IN HEIGHT. THERE WAS NO INJURY TO THE PT. THE COMPLETE CAUTERY WAS REPLACED AND THE AFFECTED ONE WAS SENT TO VALLEYLAB TO BE INVESTIGATED. THE CAUTERY MACHINE WAS CHECKED WHICH WAS NEGATIVE. PRODUCT WAS ENCLOSED IN A MAJOR SET UP PACK GENERATED BY STERILE RECOVERIES INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4497 VALLEYLAB PENCIL CAUTERY PENCIL CAUTERY GEI VALLEYLAB INC. PFIZER HOSPITAL PRODUCTS GROUP VALE230HNSB 15358

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other