BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5000 ESU- ENGLISH- 120V

    MDR report key: 6888183 · Received September 22, 2017

    Report

    Report Number
    1720159-2017-00215
    Event Type
    Malfunction
    Date Received
    September 22, 2017
    Date of Event
    January 24, 2017
    Report Date
    September 22, 2017
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K020186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED DEVICE WAS RETURNED TO CONMED FOR REPAIR SERVICE EVALUATION. THE DEVICE WAS FUNCTIONALLY AND VISUALLY INSPECTED. THE EVALUATION FOUND THE MONOPOLAR OUTPUT WAS FAILING, DUE TO BROKEN COMPONENTS IN NEED OF REPLACEMENT, LED LIGHTS WERE STROBING, AND THE SOFTWARE NEEDED AN UPGRADE. NO ISSUES WERE IDENTIFIED WITH THE BIPOLAR PORT. PER THE SERVICE AND REPAIR ENGINEER, THE BROKEN CONNECTOR WOULD NOT CAUSE SPARKING/SMOKING OR ANY CHANGE TO THE LEDS OF THE FRONT CONTROL PANEL. A REVIEW OF THE MANUFACTURING DOCUMENTS WAS NOT CONDUCTED DUE TO THE AGE OF THE DEVICE. BASED ON THE SERIAL (B)(4), THIS DEVICE WAS MANUFACTURED IN 2009. A HISTORICAL REVIEW OF COMPLAINT DATA REVEALED ONE SIMILAR COMPLAINT FOR THIS DEVICE FAMILY AND FAILURE MODE. (B)(4). A RISK ANALYSIS WAS PERFORMED AND FOUND THIS FAILURE MODE AND OCCURRENCE LEVEL TO BE ACCEPTABLE AND CONSISTENT WITH CURRENT RISK DOCUMENTS. THE INSTRUCTIONS FOR USE ADVISE THE USER OF THE FOLLOWING. - THIS ELECTROSURGICAL UNIT SHOULD BE TESTED BY A HOSPITAL QUALIFIED BIOMEDICAL TECHNICIAN ON A PERIODIC BASIS TO ENSURE PROPER AND SAFE OPERATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    DURING A LAMINECTOMY AND DISCECTOMY PROCEDURE, A SYSTEM 5000 120 V, WAS REPORTED TO NOT BE FUNCTIONING AS EXPECTED. WHILE THE DOCTOR WAS USING THE BIPOLAR MODE, THE UNIT STARTED SMOKING AT CORD AND BIPOLAR CONNECTION, WITH SPARKS AND LIGHTS COMING FROM THE UNIT. ALTHOUGH NO PATIENT INJURY WAS REPORTED, THE DOCTOR FELT THE PATIENT WAS SHOCKED DURING THIS EVENT. FOLLOW UP WITH THE USER FACILITY ON FEBRUARY 8TH, 2017 CONFIRMED THERE WAS NO PATIENT INJURY DUE TO THIS EVENT. THIS REPORT IS MADE BASED ON A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667638 SYSTEM 5000 ESU- ENGLISH- 120V ESU/SYSTEM 5000 GEI CONMED ELECTROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1