Device product
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Z-1209-2022
Product summary
- Event
- Event 89641
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 140,519 boxes (843,113 individual units)
- Official record key
device-enforcement:Z-1209-2022
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: 00886874115664. 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.