BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ES GENERATOR - 120 VOLT

    MDR report key: 1063356 · Received June 19, 2008

    Report

    Report Number
    1717344-2008-00263
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 28, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON FOLLOW-UP WITH THE SITE, THEY REPORTED A 3RD PARTY CAME IN AND CHECKED THE GENERATOR AND FOUND THAT THE GENERATOR CHECKED OUT OK. THE SITE PUT THE UNIT BACK IN SVC AND HAS HAD NO FURTHER PROBLEM WITH IT. THEY INDICATED THERE WAS NO NEED TO RETURN THE UNIT FOR EVAL.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE SITE HAS A FORCEEZ GENERATOR AND RECENTLY 2 PTS HAVING A POLYPECTOMY HAD TO BE BROUGHT BACK BECAUSE OF BLEEDING. THIS HAS NOT HAPPENED BEFORE AND THE UNIT HAD RECENTLY BEEN REPAIRED. TWO COMPLAINTS WERE OPENED, THE OTHER IS ON REPORT # 1717344-2008-00262.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ES GENERATOR - 120 VOLT ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other