8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA Th

FDA device recall Z-1442-2013 · posted 2013-05-31 · Terminated

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

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 taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NAY

Quantity affected

~132,441 instruments

Distribution

Worldwide distribution - USA (nationwide) Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyp

Date initiated

2013-05-08

Date posted

2013-05-31

Date terminated

2014-05-01

Location

Sunnyvale, CA

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