BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1031318 · Received April 18, 2008

    Report

    Report Number
    2955842-2008-00209
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Report Date
    April 18, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING INSPECTED THE INSTRUMENT AND CONFIRMED THAT THERE IS MATERIAL REMOVED FROM BOTH YAW PULLEYS DUE TO BURNING, ON THE SAME SIDE AS ONE CONDUCTOR WIRE. THE CONDUCTOR WIRE IS DETACHED FROM THE GRIP AS A RESULT. THE YAW PULLEYS EXHIBIT LOCALIZED MELTING. CHARRING/MELTING IS LIKELY DUE TO REPEATED ACTIVATION OF CAUTERY WITHOUT TISSUE BETWEEN GRIPS. HIGH GENERATOR SETTINGS MAY HAVE CONTRIBUTED TO THE DAMAGE. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS A SECTION WITH LIGHT MATERIAL REMOVAL ALL AROUND THE TUBE. DAMAGED AREA IS 2.5 " LONG, PARALLEL TO THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE MAY HAVE BEEN CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE WAS FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE, PLASTIC AROUND THE JAW OF A MARYLAND BIPOLAR FORCEPS INSTRUMENT BROKE. A BROKEN CAUTERY CABLE WAS ALSO REPORTED AND THAT NO COMPONENTS FELL INTO THE PT. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420172-06 1510071 918

    Patients

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