BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    (D) ELECTROSURFICAL GENERATOR X1

    MDR report key: 3983227 · Received June 27, 2014

    Report

    Report Number
    1717344-2014-00558
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT UNIT 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 THE PT RECEIVED A SECOND DEGREE BURN. THE BURN WAS TREATED WITH FITOSTIMOLINE GAUZE. THE CUSTOMER ADVISED THAT NO FURTHER DETAILS WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377310 (D) ELECTROSURFICAL GENERATOR X1 ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK