BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDEVAC W/ COATED BLADE, 10FT. TUBING HOLST

    MDR report key: 3983131 · Received June 30, 2014

    Report

    Report Number
    2320762-2014-00013
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 27, 2014
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    GEI
    PMA / PMN Number
    K944265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PENCIL WORKS WITHOUT SURGEON INITIATING USAGE. HAS BEEN REPORTED THAT THIS HAS HAPPENED IN THE PAST, AND PROBLEM WAS WITH THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381353 EXTENDEVAC W/ COATED BLADE, 10FT. TUBING HOLST ELECTROSURGICAL, CUTTING AND COAGULATIO GEI DEROYAL INDUSTRIES 34989144

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention