BEUDAMED
    FDA Recall Terminated

    8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.

    Recall: Z-1442-2013 · Initiated May 8, 2013

    Recall

    Recall Number
    Z-1442-2013
    Event Number
    65216
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 8, 2013
    Posted
    May 31, 2013
    Terminated
    May 1, 2014
    Address
    1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

    Description

    8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.

    Reason

    Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.

    Action

    Intuitive Surgical sent an Urgent Medical Device Recall letter dated May16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that they did not need to quarantine or return the affected device at that time. a Intuitive Surgical representative would contact them to arrange for replacement of the affected product once they became available. In the interim customers were instructed to follow the precautions and warnings outlined in Attachment A in the letter as well as the Instructions for Use. Customers were also asked to ensure all affected personnel were fully informed of the contents of the Recall Notification. The letter should be forwarded to other surgeons and/or managers within their facility. Customers were also asked to complete and return the attached Acknowledgement Form. For further questions customers were instructed to contact Customer Service: North and South America: 800-876-1310 Option 3 Japan: 0120-56-5635 or 003-5575-1362 Korea: 02-3271-3200 Europe, Middle East, Asia and Africa +800 0821 2020 or +41 21 821 2020 For questions regarding this recall call 408-523-2244.

    Distribution

    Worldwide distribution - USA (nationwide) Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Poland, Qatar, Russia, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, United Kingdom, Saudi Arabia, Singapore, South Korea, and Venezuela.

    Quantity

    ~132,441 instruments