Device product
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Z-1210-2022
Product summary
- Event
- Event 89641
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed
- Official record key
device-enforcement:Z-1210-2022
Official wording
Reason: Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Code information: UDI: 00886874117309. All lots
Distribution pattern: Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam.
Derived failure modes
-
Unknown
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.