DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Reported: June 8, 2022 Initiated: March 3, 2022 #Z-1210-2022
Product Description
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Reason for Recall
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed
- Distribution
- 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.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440. Recalled by Intuitive Surgical, Inc.. Units affected: 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed.
Why was this product recalled? ▼
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1210-2022.
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