30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci
FDA device recall Z-0653-2016 · posted 2016-01-14 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- 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.
- 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)
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 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, Netherlan
- Date initiated
- 2015-11-23
- Date posted
- 2016-01-14
- Date terminated
- 2016-04-05
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES (K131861) | Intuitive Surgical, Inc. | 2014-03-28 |