VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Reported: June 8, 2022 Initiated: March 3, 2022 #Z-1209-2022
Product Description
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
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
- 140,519 boxes (843,113 individual units)
- 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? ▼
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422. Recalled by Intuitive Surgical, Inc.. Units affected: 140,519 boxes (843,113 individual units).
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-1209-2022.
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