BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP PNCL W/HLSTR BULKPAK

    MDR report key: 1636052 · Received March 9, 2010

    Report

    Report Number
    1717344-2010-00148
    Event Type
    Malfunction
    Date Received
    March 9, 2010
    Date of Event
    November 15, 2009
    Report Date
    February 12, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED. THE SECOND PENCIL FROM PROCEDURE WAS NOT SAVED ONLY THE PACKAGING WHICH IDENTIFIED THE LOT #.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE APPEARED TO BE A CRACK IN THE PENCIL THAT CAUSED A 2ND DEGREE BURN ON THE RIGHT BREAST DURING A BREAST RECONSTRUCTION. TWO PENCILS, ONE FROM THE CUSTOM PROCEDURE TRAY PROVIDED BY MEDLINE AND ONE FROM THE SINGLE STERILE PACKAGE WERE BEING USED. THE TWO PENCILS ARE IDENTICAL ITEMS. AFTER IRRIGATION, THE SURGEON NOTICED A 1.5 CM BY 5 CM AREA OF REDNESS. THE SURGEON EXAMINED ONE OF THE PENCILS AND NOTICED THE LAST INCH OF PENCIL ALONG THE SEAM APPEARED TO BE CHARRED AND AN AREA OF THE TIP CHARRED. THE PT WAS TREATED BY EXCISING THE TISSUE. THERE WAS NO POST SURGICAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP PNCL W/HLSTR BULKPAK ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR E2516H - ELECTROSURGICAL PENCIL - LOT# 168705