BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDED COATED BLADE

    MDR report key: 3192398 · Received June 18, 2013

    Report

    Report Number
    1717344-2013-00424
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SURGERY, WHILE CUTTING THROUGH MESENTERY, THE TOP OF THE ELECTRODE CAUGHT FIRE. THERE WAS NO INJURY TO THE PATIENT. THE POWER SETTING WAS 3 BARS ON THE GENERATOR. THEY CHANGED TO ANOTHER ELECTRODE AND THE PROCEDURE CONTINUED WITHOUT ANY FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277213 EXTENDED COATED BLADE ES ACCESSORY GEI COVIDIEN LP 245091X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FT3000 PENCIL: L/N UNK| FORCE TRIAD GENERATOR: S/N (B)(4)