BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP PNCL W/HLSTR BULKPAK

    MDR report key: 1580664 · Received January 6, 2010

    Report

    Report Number
    1717344-2009-00689
    Event Type
    Malfunction
    Date Received
    January 6, 2010
    Date of Event
    January 1, 2009
    Report Date
    December 11, 2009
    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 SAMPLE HAS BEEN REQUESTED, BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD JUST STARTED THE PROCEDURE AND DONE THE INITIAL INCISION WITH A SCALPEL WHEN THEY HAD SOME BLEEDERS, THEY WERE GOING TO CAUTERIZE. THEY SET THE GENERATOR AT 30 COAG AND BEFORE ACTUALLY STARTING CAUTERIZING, THEY ACTIVATED THE PENCIL IN THE SURGICAL SITE AND A FLAME APPEARED. THEY TURNED THE GENERATOR DOWN TO 20 COAG AND THE SAME THING HAPPENED AGAIN. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP PNCL W/HLSTR BULKPAK ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 165239

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR