DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling the DAVINCI Energy SynchroSeal da Vinci X and da Vinci Xi Single Use Instruments (8mm, REF 480440) due to a hazard where placing excessive tissue in the instrument jaws prior to sealing and transection can result in an insufficient seal. The affected devices were distributed worldwide, including nationwide in the US and across numerous other countries. Approximately 7,995 boxes (47,972 individual units) have been identified as part of this recall, with the total quantity expected to increase until updated user documentation is distributed to users. All lots of the product are affected, as identified by UDI 00886874117309.
The recall notice does not specify a remedy or what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Reason for recall: Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. 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, Pan 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 Lot/code info: UDI: 00886874117309. All lots
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.