Device product
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
Z-1459-2022
Product summary
- Event
- Event 90332
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 62,895 Clip appliers
- Official record key
device-enforcement:Z-1459-2022
Official wording
Reason: Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Code information: Model/Model Number/UDI Number Da Vinci S/Si Large Clip Applier / 420230 / 00886874111680 Da Vinci S/Si Medium-Large Clip Applier / 420327 / 00886874111826 Da Vinci S/Si Small Clip Applier / 420003 / 00886874111161 Serial Numbers: All
Distribution pattern: 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.
Derived failure modes
-
Unknown
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.