According to the reporter, during a video-assisted thoracic surgery lobectomy, while the device was being applied to the pulmonary vein, when the device was fired, it stopped at the central part.After that, its adapter rotated automatically without any manipulation.The jaws of the device locked on tissue.The product was changed to complete the case.There was no patient injury.
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual and functional evaluation of the handle noted no abnormalities.Evaluation of the electrically erasable programmable read-only memory(eeprom) noted that the code was present.This was indicative of a thick tissue application and could confirm the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the device error codes may occur of the powered handle stops firing before the lower clamp reaches the distal end, which is likely due to the firing force reaching the upper design limit of the endo gia reload.This may occur under the following conditions.Application over tissue that is beyond the recommended thickness range.Application with an obstacle incorporated in the jaws.In either scenario, staples may not form properly and tissue may not be fully transected.If information is provided in the future, a supplemental report will be issued.
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