BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E. S. UNIT, STD 110V/220V

    MDR report key: 2222428 · Received July 14, 2011

    Report

    Report Number
    1717344-2011-00567
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Report Date
    June 17, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT RECEIVED A BURN DURING A LEEP PROCEDURE AFTER AN UNK TYPE OF PENCIL SPARKED. THE DEGREE OF BURN AND TREATMENT OF THE BURN ARE NOT KNOWN. ADDITIONAL QUESTIONS ABOUT THE INCIDENT HAVE BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E. S. UNIT, STD 110V/220V ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNKNOWN PENCIL - LOT UNK.