BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP INSTRUMENT

    MDR report key: 1232783 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01377
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND ONE GRIP STUCK IN A NEUTRAL POSITION. THE GRIPS WOULD NOT DISLODGE FROM NEUTRAL POSITION EVEN BY APPLYING HIGH TORQUE MANUALLY AT THE INSTRUMENT INPUT DISCS. THE INSTRUMENT WAS DISASSEMBLED AND 2 HYPOTUBES WERE FOUND STUCK TO EACH OTHER AT THE DISTAL ENDS VIA DRIED BIO DEBRIS. THE HYPOTUBE STICKING PREVENTED THE GRIP MOTION. FAILURE DUE TO IMPROPER CLEANING METHODS. ENGINEERING ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAS 1.750 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. DEEP SCRATCHES WERE FOUND ON THE SAME SECTION OF TUBE, ON THE OPPOSITE SIDE FROM THE TUBE ABRASIONS. SCRATCHES WERE LIKELY CAUSED BY 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. 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 THE ENDOWRIST PROGRASP INSTRUMENT JAWS WILL NOT OPEN. 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 ENDOWRIST PROGRASP INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420093-07 S10080819 810

    Patients

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