BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE TRIVERSE ES DEVICE COATED BLADE

    MDR report key: 2113022 · Received May 25, 2011

    Report

    Report Number
    1717344-2011-00413
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 12, 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 SAMPLE HAS BEEN REQUESTED BUT TO DATE, HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PENCIL WAS USED FOR A CERVICAL LYMPH NODE REMOVAL. THE GAUZE PLACED 10 CM FROM THE TIP OF THE PENCIL WAS IGNITED. THE GENERATOR WAS SET AT ABOUT 35W, COAG. RUBBER MATERIAL WAS USED AS INSULATION. ISODINE ANTISEPTIC SOLUTION WAS USED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE TRIVERSE ES DEVICE COATED BLADE ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK