BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKERSWITCH PENCIL

    MDR report key: 4862834 · Received June 23, 2015

    Report

    Report Number
    1717344-2015-00454
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 8, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE#: (B)(4). DATE OF INITIAL REPORT: (B)(6) 2015. DATE OF FOLLOW-UP REPORT: (B)(6) 2015. EVALUATION OF THE RETURNED PENCIL FOUND NO UNUSUAL EFFECTS WHEN THE PENCIL WAS ACTIVATED. TESTING FOUND THE PENCIL TO FUNCTION NORMALLY. THE INSTRUCTIONS FOR USE STATE DO NOT PLACE ACTIVE ACCESSORIES NEAR OR IN CONTACT WITH FLAMMABLE MATERIALS (SUCH AS GAUZE OR SURGICAL DRAPES). ELECTROSURGICAL ACCESSORIES WHICH ARE ACTIVATED OR HOT FROM USE CAN CAUSE A FIRE. USE A HOLSTER TO HOLD ELECTROSURGICAL PENCILS AND SIMILAR ACCESSORIES SAFELY AWAY FROM PATIENTS, SURGICAL TEAM, AND SURGICAL DRAPES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. 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 DURING THE PROCEDURE A PIECE OF GAUZE ON THE INSTRUMENT TRAY WAS BURNED WHEN THE PENCIL TOUCHED IT. THE FIRE WAS EXTINGUISHED IMMEDIATELY WITHOUT HARM TO THE PATIENT OR O.R. PERSONNEL. ANOTHER PENCIL WAS USED TO COMPLETE THE PROCEDURE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404862 ROCKERSWITCH PENCIL ES ACCESSORY GEI COVIDIEN LP E2350H

    Patients

    Seq Age Sex Outcome Treatment
    1