BEUDAMED
    FDA Recall Terminated

    Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.

    Recall: Z-0521-2014 · Initiated November 15, 2013

    Recall

    Recall Number
    Z-0521-2014
    Event Number
    66918
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    November 15, 2013
    Posted
    December 16, 2013
    Terminated
    September 4, 2014
    Address
    1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

    Description

    Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.

    Reason

    Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.

    Action

    Intuitive Surgical sent a Field Safety Notice dated November 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure all appropriate personnel are fully informed of the Notification. Discontinue use of affected product, Use the attached instructions to identify and segregate affected product. Return affected product to Intuitive Surgical following the established Returned Materials Authorization (RMA) process. Complete the Acknowledgement Form and return to Intuitive Surgical. Customers with questions were instructed to contact Intuitive Surgical Customer Service. Customers were asked to retain a copy of this letter and the acknowledgement form for their files. For questions regarding this recall call 800-876-1310, option 3. Japan 0120-56-5635 or 03-5575-1362 South Korea 02-3271-3200 Europe, Middle East, Asia and Africa +800 0821 2020 +41 21 821 2020 For questions regarding this recall call 408-523-2100. Urgent Medical Device Recall notification letters were sent to all affected sites on November 15, 2013.

    Distribution

    Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia.

    Quantity

    94, 981 UPDATED 12/19/13 to 56, 469