BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1063554 · Received June 20, 2008

    Report

    Report Number
    2955842-2008-01081
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 24, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING FOUND THE TUBE EXTENSION TO BE DISLODGED FROM THE MAIN TUBE. THE ENTIRE TUBE EXTENSION WALL IS BROKEN AT THE BASE OF THE AXIAL KEYS RESULTING IN THE TUBE EXTENSION HAVING THE ABILITY TO ROTATE 360 DEGREES. NO PIECES ARE MISSING. ENGINEERING HAS CONCLUDED THAT THE DAMAGE MAY BE DUE TO EXCESSIVE SIDE LOADING. ENGINEERING ALSO OBSERVED THE MAIN TUBE TO HAVE LIGHT MATERIAL REMOVED ALL AROUND THE TUBE FROM THE MIDPOINT TO THE DISTAL END. THE DAMAGE AREA IS PARALLEL TO 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

    THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS RETURNED WITH AN UNKNOWN PROBLEM. 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. 420179-08 0910071 095

    Patients

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