BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP HNDSW PENCIL W/HOLSTER

    MDR report key: 1033034 · Received April 22, 2008

    Report

    Report Number
    1717344-2008-00162
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Report Date
    March 26, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE WAS SENT AN INFORMATIONAL PACKET ON OR FIRE SAFETY. THE SAMPLE HAS BEEN REQUESTED, BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A PROCEDURE THE ELECTROSURGICAL PENCIL WAS SPARKING AND IGNITED AND CHARRED A RAYTEX SPONGE. THE SURGEON TRIED CHANGING THE GENERATOR, TIP AND CHECKED THE PAD PLACEMENT AND STILL THE ISSUE PERSISTED. THEY CHANGED PENCIL TO ONE FROM THE SAME LOT NUMBER AND THE SPARKING PERSISTED. THE STAFF THEN CHANGED TO A NEW LOT NUMBER AND THE SPARKING STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP HNDSW PENCIL W/HOLSTER ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 131269

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK