BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4" EDGE BLADE INSULATED

    MDR report key: 1904221 · Received November 15, 2010

    Report

    Report Number
    1717344-2010-00866
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED, BUT TO DATE, HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D, OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PLASTIC CAME OFF THE ELECTRODE AND FELL INTO THE PT CAVITY. ALL PIECES WERE RETRIEVED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4" EDGE BLADE INSULATED ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK