According to the reporter, during a laparoscopic assisted distal gastrectomy procedure, on the second firing for the stomach, the surgeon pushed the green firing mode button, but the device did not fire.Then the surgeon tried to release the tissue from the cartridge, but the jaws suddenly articulated.The surgeon was able to release it from the tissue eventually, without damaging it.The nurse then tried to remove the cartridge from the adapter, but was not able to.The cartridge was connected to the adapter and the blue button was pressed and the device did not react but the jaws articulated on its own.The current patient status is okay.
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(b)(4).Post market vigilance (pmv) led an evaluation of one device.Visual and functional evaluation of the handle noted no abnormalities.Visual and functional testing of the returned product confirmed the product, as received, met release specifications.Product analysis suggests the product was used in a surgical procedure.No enhancements or improvements were generated for the reported condition.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
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