Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
- Company
- Intuitive Surgical, Inc.
- Recall Initiated
- July 1, 2022
- Recall Number
- Z-1460-2022
- Quantity
- 90,628 Clip appliers
- Firm Location
- Sunnyvale, CA
Reason for Recall
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Lot / Code Info
Model/Model Number/UDI Number Da Vinci X/Xi Large Clip Applier / 470230 / 00886874112380 Da Vinci X/Xi Medium-Large Clip Applier / 470327 / 00886874112465 Da Vinci X/Xi Small Clip Applier / 470401 / 00886874112670 Serial Numbers: All
Root Cause
Nonconforming Material/Component
Action Taken
On 07/01/2022, Intuitive Surgical sent an "Urgent Medical Device Correction" Letter to customers via FedEx courier informing them there is the potential for unexpected motion while using the da Vinci S/Si and X/Xi Endowrist Clip Applier Instruments. This can happen when one of the da Vinci S/Si and X/Xi Clip Applier grip discs are disengaged from the sterile adapter disc during the engagement routine that occurs prior to insertion of the instrument into the cannula and into the patient. To mitigate this issue, Intuitive Surgical has developed a Clip Applier Manual Self-Test (Appendix A) that is part of the Urgent Medical Device Correction Letter. This test is performed by moving the Clip Applier grips through the full range of yaw motion (side-to-side in the plane of the instrument grips) and observing the movement of both the instrument grips prior to placing a clip around a vessel/tissue. This test should be performed in an open space to prevent any collisions. Pass Criteria " During the yaw movement, if the grips remain open with no observation of grips closing then the instrument passes the self-test and users may proceed with using the clip applier instrument in a procedure. Fail Criteria " During yaw movement, if the grips begin to close as opposed to the grips remaining open then there is potential that one of the grip discs is not engaged. Instrument should be removed, reinstalled, and inspected for engagement. If the self- test fails, remove Clip Applier instrument, re-install and repeat self-test. If it fails again, use a different Clip Applier instrument and return the instrument using the standard Intuitive RMA process. Please call customer service to return the affected product using the appropriate local number listed in section 6 of the letter. Credit will be issued when the reported unexpected motion is confirmed. For questions: " US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg