BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1203499 · Received October 17, 2008

    Report

    Report Number
    2955842-2008-01326
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED TESTS AND FOUND THE INSTRUMENT SCISSORS DID NOT CUT CLEANLY THROUGH .006" OF LATEX. THE LATEX GETS SNAGGED AT THE SCISSORS TIPS, BUT THE BLADES ARE NOT DAMAGED. THE BLADE EDGES ARE SLIGHTLY ROUNDED AT THE TIPS, NEGATIVELY AFFECTING CUT PERFORMANCE. THE DECREASED CABLE TENSION AND/OR BELLEVILLE SPRING FORCE MAY ALSO BE CONTRIBUTING TO THE POOR CUTTING PERFORMANCE. ELECTRICAL CONTINUITY PASSED. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAD A .935" LONG SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO THE TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE 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 SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DULL. NO ADDITIONAL INFO WAS PROVIDED. 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 INSTRUMENT GEI INTUITIVE SURGICAL, INC. 400179-08 S10080708 533

    Patients

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