BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1041285 · Received May 9, 2008

    Report

    Report Number
    2955842-2008-00273
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 OBSERVED THAT THE INSTRUMENT CUT CLEANLY AND AS INTENDED. THE BLADES ARE NOT DAMAGED AND ELECTRICAL CONTINUITY PASSED. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS TWO DISTINCT SECTIONS LOCATED ABOVE AND BELOW THE MIDPOINT WITH MATERIAL REMOVED. DAMAGED AREAS ARE BOTH ROUGHLY 2.5" LONG, PARALLEL TO TUBE AXIS WITH A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE AREA BELOW THE MIDPOINT MAY HAVE BEEN CAUSED BY A CANNULA ACCESSORY. THE DAMAGE ABOVE THE MIDPOINT AREA APPEARS TO HAVE BEEN CAUSED BY HIGH PRESSURE AGAINST THE CANNULA BOWL/TUBE TRANSITION. NO OTHER DAMAGE FOUND. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DULL. NO ADD'L 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 0712281 062

    Patients

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