BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTWAVE SUCTION ABLATOR

    MDR report key: 1122284 · Received August 13, 2008

    Report

    Report Number
    1017294-2008-00291
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: CONMED LINVATEC IS UNABLE TO EVALUATE THIS UNIT, BECAUSE IT WAS DISCARDED AT THE USER FACILITY. SIMILAR DEVICES HAVE BEEN RETURNED FOR THIS SAME FAILURE MODE AND A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS FAILURE MODE. ASSOCIATED MDR: 1017294-2008-00288. THE OTHER UNIT ASSOCIATED WITH THIS EVENT WAS RETURNED FOR EVALUATION. THE ABLATOR HANDLE ON THE RETURNED SUCTION ABLATOR WAS DISASSEMBLED AND A VISUAL EXAMINATION FOUND SALT LIKE DEPOSITS UNDER THE DOME SWITCHES OF THIS DEVICE. THIS TYPE OF FAILURE MAY CONTRIBUTE TO THE REPORTED PROBLEM. A CORRECTIVE ACTION IS IN PROGRESS TO ADDRESS THIS FAILURE MODE. THE INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER: WHEN NOT IN USE, PLACE THE DEVICE IN A SAFE AND HIGHLY VISIBLE ARE NOT IN CONTACT WITH THE PATIENT. INADVERTENT ACTIVATION WHILE IN CONTACT WITH THE PATIENT MAY RESULT IN BURNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS SUCTION ABLATOR, IT OPERATED ON ITS OWN WITHOUT ENGAGING THE ON SWITCH. THE USER REPORTED THE DEVICE WAS PLUGGED INTO THE GENERATOR AND SITTING ON THE BACK STERILE TABLE WHEN IT ACTIVATED. THIS ABLATOR WAS UNPLUGGED AND DISCARDED. ANOTHER ABLATOR WAS OBTAINED FOR USE. THE USER REPORTED THAT THE SAME EVENT OCCURRED WITH THIS ABLATOR. THE SURGEON PLACED THE DEVICE IN STANDBY MODE AND WAS ABLE TO COMPLETE THE SURGERY WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTWAVE SUCTION ABLATOR SUCTION ABLATOR GEI CONMED LINVATEC NA NK

    Patients

    Seq Age Sex Outcome Treatment
    1 NK NK