BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 1071376 · Received July 7, 2008

    Report

    Report Number
    2955842-2008-01116
    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 FOUND A DECREASE IN THE CABLE TENSION THAT COULD REDUCE THE GRASPING FORCE. THE CARBIDE TEETH ARE NOT DAMAGED. ENGINEERING ALSO FOUND THE DISTAL END OF THE MAIN TUBE HAS AN AREA ON ONE SIDE OF THE TUBE WITH VARIOUS LIGHT SCRATCHES AND ONE DEEP SCRATCH WITH MATERIAL REMOVED. THE DEEP SCRATCH IS LOCATED 1.5 INCHES ABOVE THE PROXIMAL CLEVIS AND IS NOT ALIGNED TO THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A INSTRUMENT COLLISION. NO OTHER DAMAGE FOUND. 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 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 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420006-05 0801222 133

    Patients

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