BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC GRASPER INSTRUMENT

    MDR report key: 1191167 · Received September 26, 2008

    Report

    Report Number
    2955842-2008-01292
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED PERFORMANCE TESTS AND FOUND THAT THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. RECOGNITION AND ENGAGEMENT PASSED. RESULTS/CONCLUSIONS - ENGINEERING ALSO OBSERVED THAT THE DISTAL END OF MAIN TUBE HAS A 2.380" LONG SECTION, EXTENDING FROM THE INTERSECTION BETWEEN THE PROXIMAL CLEVIS AND THE MAIN TUBE TOWARD THE HOUSING, WITH MATERIAL REMOVED ON DIFFERENT PARTS OF THE TUBE. THE DAMAGED AREA HAS A ROUGH SURFACE FINISH, COMBINED WITH DEEP SCRATCHES WITHIN THE SAME AREA. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A COMBINATION OF CANNULA ACCESSORY AND INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. CONCLUSIONS: THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE OT THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THORACIC GRASPER INSTRUMENT WAS NOT WORKING PROPERLY. 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 THORACIC GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420208-05 0711091 717

    Patients

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