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U.S. Department of Health and Human Services

Class 2 Device Recall 5X300 MM Curved Cannula, Arm 2

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  Class 2 Device Recall 5X300 MM Curved Cannula, Arm 2 see related information
Date Initiated by Firm March 13, 2014
Date Posted April 04, 2014
Recall Status1 Terminated 3 on September 03, 2014
Recall Number Z-1333-2014
Recall Event ID 67758
510(K)Number K112208  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product 5X300 MM Curved Cannula, Arm 2
for use with daVinci SI Surgical System, model number IS3000.

Intuitive Surgical
1266 Kifer Road
Sunnyvale, CA 94086

The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
Code Information Part number 428062-03: Lot numbers:  VE105003 VE120304 VE121402 VE121903 VE122704 VE123101 VE111202 VE120402 VE121502 VE121905 VE122705 VE123103 VE114502 VE120504 VE121506 VE122201 VE122707 VE123105 VE114602 VE120902 VE121512 VE122202 VE122903 VE115202 VE121003 VE121606 VE122303 VE123005 VE120202 VE121113 VE121702 VE122501 VE123012.
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
Manufacturer Reason
for Recall
Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
FDA Determined
Cause 2
Device Design
Action Intuitive sent an Urgent Medical Device letter dated March 25, 2014, to all users of cannulas that have the potential to be damaged during use as well as a second letter to all single site cannula users that provided clarity to instruction for use for inspections and handling of the product. Certain lots manufactured prior to August of 2012, and users were asked to use Attachment A to help identify affected lots numbers. Phase 1 - Cannulas should then be inspected with information provided in Attachment B. Any damaged devices should be quarantined and returned to intuitive. If inspection does not find damage, the device may continue to be used. Any other cannulae and any non damaged product should be used according to Attachment C's instructions for use. Phase 2 - Once replacement cannulae are available, the undamaged cannulae should be returned. The Acknowledgement form should be completed and returned to Intuitive. Intuitive will contact consignees when replacement cannulae are available. Questions should be directed to Customer Service at 800-876-1310. Those consignees that use the 5 mm canulae but do not have affected product were provided with a letter that only includes the Single Site Cannula inspection and Use addendum.
Quantity in Commerce 5217 total cannulae
Distribution Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.