5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kif
FDA device recall Z-1333-2014 · posted 2014-04-04 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 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 Arabi
- Date initiated
- 2014-03-13
- Date posted
- 2014-04-04
- Date terminated
- 2014-09-03
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES (K112208) | Intuitive Surgical, Inc. | 2011-12-08 |