BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABRE 2400 ESU

    MDR report key: 753333 · Received July 25, 2006

    Report

    Report Number
    1720159-2006-00036
    Event Type
    Malfunction
    Date Received
    July 25, 2006
    Date of Event
    June 26, 2006
    Report Date
    July 25, 2006
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED TECHNICIAN IS EVALUATING THE GENERATOR ON SITE AT THE HOSPITAL ON JULY 25, 2006. WILL SEND FOLLOW UP REPORT WHEN AVAILABLE.

    Description of Event or Problem · 1

    INVOLVED IN A FLASH FIRE IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABRE 2400 ESU ELECTROSURGICAL GENERATOR GEI CONMED ELECTROSURGERY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *