BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E2783R-28ASP OPTI4 WIRE L HOOK

    MDR report key: 3192397 · Received June 18, 2013

    Report

    Report Number
    1717344-2013-00437
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A HEPATECTOMY PROCEDURE, A SPARK BURNED A HOLE IN THE SIDE OF THE INSULATED SHAFT OF THE ELECTRODE. THE OUTPUT SETTING WAS 80W IN THE COAG MODE. NO PATIENT HARM OCCURRED. A NEW ELECTRODE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276207 E2783R-28ASP OPTI4 WIRE L HOOK ES ACCESSORY GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK