BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 1071708 · Received July 9, 2008

    Report

    Report Number
    2955842-2008-01141
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THREE OF FOUR SNAP TABS WERE BROKEN OFF THE INSTRUMENT HOUSING AND TWO HOUSING PINS WERE BROKEN OFF. AS A RESULT OF THE BREAKAGE, ONE SIDE OF THE HOUSING CAN BE LIFTED UP. ENGINEERING ALSO OBSERVED THAT THE DISTAL END OF THE INSTRUMENT MAIN TUBE HAS TWO SECTIONS, 180 DEGREES APART, WITH LIGHT MATERIAL REMOVED. THE DAMAGED AREAS ARE 1 INCH AND 3 INCHES LONG, PARALLEL TO THE TUBE AXIS AND HAVE A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND THE 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 CASING OF THE LARGE NEEDLE DRIVER INSTRUMENT IS BUSTED AND NOTHING FELL INTO THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420006-05 0801072 615

    Patients

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