Recall Z-0653-2016
Intuitive Surgical, Inc. · initiated November 23, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.
Codes / lots: Model numbers: 470027-34, 470027-40, 470027-41. All lots.
Reason for recall
This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.
FDA-determined cause: Device Design
Action taken
Intuitive Surgical sent an Urgent Medical Device Correction letter to affected customers on December 4, 2015,. Letters explained the issue and provided action to follow to prevent the issue. Customers were instructed to do the following: Distribute a copy of this letter to all da Vinci Xi users at your facility. 3. Place a copy of this letter with your user manual. 4. Complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. 5. Retain a copy of this letter and the Acknowledgement Form for your files. If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST)
Details
- Recall number
- Z-0653-2016
- Initiated
- November 23, 2015
- Posted by FDA
- January 14, 2016
- Terminated
- April 5, 2016
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Quantity
- 2624 total all models
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela. .
- Recalling firm
- Intuitive Surgical, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0652-2016 Class II | 0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General…This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm… | 11/23/2015Terminated |