BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1232784 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01372
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 28, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED PERFORMANCE TESTING AND FOUND THE SCISSORS TO CUT CLEANLY THROUGH .006" LATEX. THE BLADES ARE NOT DAMAGED. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE TUBE EXTENSION TO HAVE A TRIANGULAR SHAPED CHAR MARK WITH MATERIAL REMOVED DUE TO BURNING. THE CHAR MARK IS .170" LONG AND .185" WIDE (AT TRIANGLE BASE). THE CHARRING SUGGESTS AND ARCING EVENT OCCURRED. WHEN A TIP COVER IS PLACED ON THE INSTRUMENT, THE CHAR MARK IS COMPLETELY COVERED BY THE ULTEM SLEEVE. ASSUMING A TIP COVER WAS INSTALLED DURING THE PROCEDURE, IT IS UNCLEAR IF ENERGY WOULD HAVE ESCAPED THROUGH THE SILICONE PART OF THE TIP COVER BASED ON THE LOCATION OF THE CHAR MARK. THE TUBE EXTENSION MAY HAVE HAD A CRACK WHICH FILLED WITH CONDUCTIVE BODY FLUIDS AND CREATED A PATH FOR ARCING. HIGH GENERATOR SETTINGS MAY HAVE ALSO CONTRIBUTED TO THE ARCING. ELECTRICAL CONTINUITY PASSED. NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT WERE OBSERVED TO BE DULL. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ELECTROSURGICAL ISNTRUMENT GEI INTUITIVE SURGICAL, INC. 420179-08 S10080716 319

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| ELECTROSURGICAL UNIT| DA VINCI S SURGICAL SYSTEM