BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP FORCEPS INSTRUMENT

    MDR report key: 1061783 · Received June 13, 2008

    Report

    Report Number
    2955842-2008-01069
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING UNABLE TO REPLICATE THE ISSUE WHEN CONDUCTING TESTS THAT FOUND THE INSTRUMENT WAS SUCCESSFULLY RECOGNIZED BY THE SYSTEM. THE POGO PINS DO NOT STICK AND ARE NOT CONTAMINATED. THE INSTRUMENT WAS ABLE TO MOVE INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS AND THE GRIPS OPENED AND CLOSED PROPERLY. ENGINEERING ALSO OBSERVED THAT DISTAL END OF THE MAIN TUBE HAS TWO DEEP SCRATCH MARKS AND A SCRAPE MARK WITH MATERIAL REMOVED. SCRATCHES ARE NOT ALIGNED WITH TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE SCRATCHES ARE MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS. THE SCRAPE MARK IS 180 DEGREES FROM THE SCRATCHES. THE DAMAGED AREA IS 1.2 INCHES LONG AND PARALLEL TO THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE SCRAPE 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 INFO IS RECEIVED. 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 TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A PROCEDURE THE DA VINCI S SURGICAL SYSTEM WAS NOT RECOGNIZING THE ENDOWRIST PROGRASP FORCEPS INSTRUMENT AND NOTHING FELL INTO THE PT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT OF THE SAME TYPE. 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 ENDOWRIST PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420093-07 1408071 096

    Patients

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