BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB ELECTROSURGICAL HANDSWITCHING PENCIL

    MDR report key: 134021 · Received November 17, 1997

    Report

    Report Number
    1717344-1997-00169
    Event Type
    Malfunction
    Date Received
    November 17, 1997
    Date of Event
    October 17, 1997
    Report Date
    October 17, 1997
    Manufacturer
    VALLEYLAB INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PENCIL WAS NOT RETURNED TO VALLEYLAB FOR TESTING; THEREFORE, THE ACTUAL CAUSE OF THIS EVENT IS INCONCLUSIVE. ALTHOUGH ACTUAL TESTING WAS NOT PERFORMED, CORRECTIONS TO THE PENCIL'S SWITCH BASE TO LIMIT DOWNWARD TRAVEL OF THE IDC SWITCHING PINS HAS TAKEN PLACE. THE DOWNWARD TRAVEL OF THE IDC PIN IS CAUSED WHEN EXCESSIVE FORCE IS PLACED ON THE SWITCH WHICH MAY CAUSE A SELF-ACTIVATION CONDITION. ADDITIONAL IMPROVEMENTS HAVE TAKEN PLACE TO IMPROVE THE OVER-ALL RELIABILITY OF THE PENCIL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE PENCIL SELF ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB ELECTROSURGICAL HANDSWITCHING PENCIL ELECTROSURGICAL HANDSWITCHING PENCIL GEI VALLEYLAB INC E2555DB 27812

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN