BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 1052764 · Received May 27, 2008

    Report

    Report Number
    2955842-2008-01035
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Report Date
    May 23, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLERS AND THE PULLEY SPINS FREELY. ENGINEERING CONCLUDED THAT THE CABLE BROKE UNDER TENSILE LOADING. OTHER CABLES AT THE WRIST ARE NOT DAMAGED. THE CABLE WEAR ON THE PULLEYS WITH HIGH GRASPING FORCE LIKELY CONTRIBUTED TO BREAKAGE. ENGINEERING ALSO OBSERVED THAT THE DISTAL END OF MAIN TUBE HAS A 1.75 INCH LONG SECTION WITH MATERIAL REMOVED. THE DAMAGED 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. 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 LARGE NEEDLE DRIVER INSTRUMENT WAS DEFECTIVE. NO ADDITIONAL INFORMATION WAS PROVIDED. 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 0711092 596

    Patients

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