BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGER NEEDLE DRIVER INSTRUMENT

    MDR report key: 1071378 · Received July 7, 2008

    Report

    Report Number
    2955842-2008-01115
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED PERFORMANCE TESTS AND FOUND THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTING. THE INSTRUMENT HAD A FULL RANGE OF MOTION IN ALL DIRECTIONS WITH GRIPS OPENING AND CLOSING PROPERLY. A NEEDLE WAS GRASPED AND SUTURING WAS SIMULATED WITHOUT ANY ISSUES. ENGINEERING ALSO FOUND THE DISTAL END OF THE MAIN TUBE HAS A 1.4 INCH LONG SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. 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. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A F/U MDR WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LARGE NEEDLE DRIVER INSTRUMENT IS NOT HOLDING THE NEEDLE. NO ADD'L INFO PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGER NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420006-05 0804031 956

    Patients

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