BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTWAVE SUCTION ABLATOR

    MDR report key: 1172647 · Received September 19, 2008

    Report

    Report Number
    1017294-2008-00312
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS DEVICE FOR EVAL AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. FURTHER INVESTIGATION FOUND WHEN TESTED ON A TEST GENERATOR THAT THE COAGULATION BUTTON FUNCTIONED TO SPEC; HOWEVER, THE CUT BUTTON WAS NON-FUNCTIONAL. UPON DISASSEMBLY, SALT-LIKE DEPOSITS WERE FOUND INSIDE THE UNIT UNDER THE DOME SWITCHES AND ON THE PC BOARD, WHICH INDICATED A LEAK. A SUPPLIER CORRECTIVE ACTION HAS BEEN INITIATED. A LEAK TEST IS PERFORMED ON ALL PRODUCTION UNITS PRIOR TO PACKAGING, AND A CHANGE IN CLEANING PROCESS HAS BEEN IMPLEMENTED FOR THIS DEVICE PRIOR TO BONDING. THIS FAILURE MODE REMAINS UNDER INVESTIGATION, AND CONMED LINVATEC CONTINUES TO MONITOR THIS PRODUCT FOR FAILURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS ABLATOR, THE DEVICE STARTED TO OPERATE ON ITS OWN AND WOULD NOT SHUT OFF. THERE WAS NO REPORT OF INJURY OR SURGICAL DELAY WITH THIS EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER ABLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTWAVE SUCTION ABLATOR SUCTION ABLATOR GEI CONMED LINVATEC NA 0806092

    Patients

    Seq Age Sex Outcome Treatment
    1 NK NK