Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical,

FDA device recall Z-0521-2014 · posted 2013-12-16 · Terminated

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

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

Action taken

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.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

NAY

Quantity affected

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

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,

Date initiated

2013-11-15

Date posted

2013-12-16

Date terminated

2014-09-04

Location

Sunnyvale, CA

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