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Recall Observatory FDA recall evidence

Device product

VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422

Z-1209-2022

March 03, 2022

Class II

Product summary

Firm
Intuitive Surgical, Inc.
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

    reason.no_named_rule · v1.0.0

    Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.