BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTANT RESPONSE ES GENERATOR

    MDR report key: 1030212 · Received April 14, 2008

    Report

    Report Number
    1717344-2008-00150
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 17, 2008
    Manufacturer
    COVIDIEN LP, (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT : 04/14/2008. AFTER TESTING OF THE GENERATOR CONFIRMED IT WAS OPERATING TO SPECIFICATION, THE SITE WAS CONTACTED. AFTER FINDING WHAT SETTINGS THEY WERE OPERATING AT WE CONFIRMED THAT THE COAG LOW 2 AND COAG LOW 3 MODES OUTPUT WAVEFORMS EXACTLY MATCH THE FREQUENCY AND APPEARANCE OF THE PURE CUT WAVEFORM, AND THIS CONDITION IS TO BE EXPECTED WITH A PROPERLY WORKING GENERATOR. WE EXPLAINED THIS INFORMATION IS PROVIDED IN THE SERVICE MANUAL AND THE USERS GUIDE FOR THIS GENERATOR.

    Description of Event or Problem · 1

    THE REPORT STATED THAT WHEN PRESSING ON THE COAG PEDAL THEY GOT A CUT WAVEFORM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK