BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKERSWITCH PENCIL

    MDR report key: 3222151 · Received July 2, 2013

    Report

    Report Number
    1717344-2013-00491
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(4). DATE OF INITIAL REPORT ON: (B)(4) 2013. THE INCIDENT PENCIL AND TWO ELECTRODES (ONE USED, ONE UNUSED) WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE PENCIL FOUND NO SIGNS OF HEAT DAMAGE SUCH AS MELTING OR BLACKENING. INSPECTION OF THE USED ELECTRODE NOTED SOME CHARRING ON THE ELECTRODE TIP. HOWEVER, TESTING FOUND THE PENCIL TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. NO CONDITIONS WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A C-SECTION, THE SURGEON NOTICED A SMALL CANDLE-LIKE FLAME COMING FROM THE TIP OF THE PENCIL. THERE WAS NO OPERATING ROOM FIRE OR PATIENT INJURY. THE SITE CHECKED OUT THE GENERATOR IN USE AT THE TIME AND IT WAS FOUND TO FUNCTION NORMALLY AND TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300622 ROCKERSWITCH PENCIL ES ACESSOR GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK