BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTONSWITCH PENCIL NSB

    MDR report key: 2123581 · Received June 10, 2011

    Report

    Report Number
    1717344-2011-00460
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. ONCE THE INCIDENT SAMPLE HAS BEEN RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING INCOMING INSPECTION BY COVIDIEN JAPAN QUALITY ASSURANCE PERSONNEL, THE PENCIL SELF-ACTIVATED. NO PATIENT WAS INVOLVED AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTONSWITCH PENCIL NSB ELECTROSURGICAL PENCIL GEI COVIDIEN LP (VALLEYLAB) 207113X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA