BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1230438 · Received November 7, 2008

    Report

    Report Number
    2955842-2008-01361
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING FOUND THE INSTRUMENT WAS RETURNED WITH THE LUER PLATE DISLODGED FROM THE CHASSIS. THE CHASSIS FEATURE THAT RETAINS THE LUER PLATE IS NOT BROKEN, BUT THE HOUSING HAS THE BOTTOM PART OF BOTH FRONT SNAP TABS BROKEN AND A SMALL CRACK ON THE SIDE OF THE HOUSING. HOUSING LIKELY CAME OFF DUE TO MISHANDLING CAUSING LUER PLATE TO DISLODGE. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS TWO SECTIONS PARALLEL TO THE TUBE AXIS WITH MATERIAL REMOVED. ONE SECTION IS ROUGHLY .700" LONG, LOCATED DIRECTLY ABOVE THE TUBE EXTENSION. THE OTHER SECTION IS HIGHER UP THE TUBE, ROUGHLY 1.2" LONG WITH A LIGHTER WEAR PATTERN. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGES WERE 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 THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS NOT WORKING PROPERLY, 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 0803251 278

    Patients

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