BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERIES S IGLESIAS WORKING ELEMENT

    MDR report key: 1943773 · Received December 17, 2010

    Report

    Report Number
    1519132-2010-00040
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 17, 2010
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FJL
    PMA / PMN Number
    K971881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE WORKING ELEMENT FINDS THE ELECTRODE STUCK INSIDE THE ACTUATOR BLOCK DUE TO THE DISTAL END BEING MELTED. THE INSIDE OF THE ACTUATOR BLOCK FINDS MINIMAL CHARRING (FIG. 2). THE VISUAL EXAMINATION OF THE DAC CORD FINDS CHARRING AND THE TOP PIECE OF THE METAL CONNECTOR PLUG IS SEVERELY MELTED. THE DISTAL END OF THE (B)(4) TUBE IS DAMAGED. THE MELTED METAL ON THE DISTAL END OF ELECTRODE AND JAWS OF THE DAC CORD WERE LIKELY CAUSED BY INCOMPLETE ASSEMBLY OF THE ELECTRODE TO THE ACTIVE CORD. THE PROPER PROCEDURE NOTED IN THE IFU REQUIRES THE ELECTRODE TO BE FULLY INSERTED UNTIL IT LOCKS IN PLACE, THEN THE CORD IS TO BE PUSHED INTO THE OPENING AND ENGAGED WITH THE ELECTRODE TIP. IF THE USER ASSEMBLES THE PIECES INCORRECTLY BY INSERTING THE DAC CORD FIRST FOLLOWED BY THE ELECTRODE, THE ELECTRODE CANNOT BE FORCED INTO THE JAWS OF THE DAC CONNECTOR AND INSTEAD IS LOOSELY BUTTING AGAINST THE CONNECTOR. THIS SITUATION RESULTS IN AN INTERMITTENT CONNECTION THAT PRODUCES ARCING AND SPARKING BETWEEN THE TWO PIECES. THE DAMAGE TO THE (B)(4) TUBE ASSEMBLY IS THE RESULT OF EXCESSIVE LATERAL FORCES EXERTED BY THE USER DURING INSERTION OR EXTRACTION FROM THE INNER SHEATH DURING A PROCEDURE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, WHILE USING THE SERIES S IGLESIAS WORKING ELEMENT, THE WORKING ELEMENT FROM THE RESECTOSCOPE TRAY SPARKED, THE ELECTRODE BURNT BY THE BALL TIP, AND IT COULD NOT BE REMOVED FROM THE INSTRUMENT. THERE WAS NO PT INVOLVEMENT, BUT THE SURGEON WAS ZAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES S IGLESIAS WORKING ELEMENT IGLESIAS WORKING ELEMENT FJL GYRUS ACMI, INC. 16949E

    Patients

    Seq Age Sex Outcome Treatment
    1