BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR

    MDR report key: 1100126 · Received August 5, 2008

    Report

    Report Number
    1717344-2008-00338
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 11, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT : 08/05/2008. 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 REPORT STATED THAT DURING PREPARATION FOR SURGERY STRANGE SOUNDS WERE HEARD FROM INSIDE THE GENERATOR WHEN IT WAS SWITCHED ON. THEN SPARKS FELL TO THE FLOOR AND THE FLOOR WAS SLIGHTLY BURNED. THERE WERE NO INJURIES TO ANYONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK