BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 2140685 · Received June 9, 2011

    Report

    Report Number
    2140685
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    March 28, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CONMED
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    CONMED REUSABLE MONOPOLAR ESU ELECTROSURGICAL UNIT CORD. DURING THE PROCEDURE, THE MONOPOLAR CORD SPARKED AND FLEW OFF AT THE CONNECTOR SITE WHERE CORD ATTACHES TO METAL ATTACHMENT THAT GOES IN THE BOVIE MACHINE. METAL MONOPOLAR ATTACHMENT STAYED IN MACHINE. ANOTHER MONOPOLAR CORD ATTACHED, NO FURTHER PROBLEMS NOTED DURING THE CASE. MONOPOLAR CORD, BOVIE PLATE SAVED. BOVIE MACHINE REMOVED FROM ROOM AT END OF PROCEDURE. BIOMED BIOMEDICAL ENGINEERING WAS NOTIFIED. BIOMED TESTED THE VALLEYLAB ESU AND NO PROBLEMS WERE FOUND WITH THE ESU. THE CONMED REUSABLE MONOPOLAR CORD THAT CONNECTS TO THE FRONT OF ESU BECAME DETACHED FROM THE PLUG AFTER IT SPARKED. THE MOST LIKELY CAUSE WAS DUE TO DEGRADATION IN THE WIRE NEAR THE STRAIN RELIEF OF THE PLUG BY BEING FLEXED TOO MANY TIMES WHICH CAUSED THE CURRENT TO ARC INSIDE THE CABLE. THE CPD/OR MANAGER AND DIRECTOR WERE NOTIFIED WITH THE RECOMMENDATION OF REPLACING REUSABLE CABLES AFTER 20 USES TO HELP PREVENT A SIMILAR OCCURRENCE FROM HAPPENING AGAIN OR THAT THEY CONSIDER USING DISPOSABLE MONOPLOAR CORDS. ALSO RECOMMENDED RE-IN SERVICING ALL STAFF THAT PROCESSES THE CABLES TO PERFORM VISUAL INTEGRITY TESTING OF THE CABLES DURING PROCESSING. CLINICAL ENGINEERING IS EVALUATING IF THERE ARE ANY TEST EQUIPMENT THAT CAN BE USED TO CHECK FOR COMPROMISED CORDS AND CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MONOPOLAR ESU CORD GEI CONMED UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR