BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCIESSORS INSTRUMENT

    MDR report key: 1083233 · Received July 24, 2008

    Report

    Report Number
    2955842-2008-01157
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONDUCTED A CUT TEST AND THE SCISSORS PERFORMED AS INTENDED. THE INSTRUMENT BLADES WERE NOT DAMAGED. THE CUSTOMER ALLEGED FAILURE MODE COULD NOT BE CONFIRMED. ENGINEERING ALSO OBSERVED THAT ONE SIDE OF THE DISTAL END OF THE MAIN TUBE AS A 1.5 INCH LONG SECTION WITH MATERIAL REMOVED. 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 INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DULL. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCIESSORS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420179-08 0802151 127

    Patients

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