According to the reporter, at the first firing of bypass of gastroenterostomy, at jejunum resection (lifted-up jejunum construction) , the cartridge was connected to the instrument, then the surgeon started firing the device, however the knife advanced by only 1cm then the firing stopped.The staples of the proximal end appeared from the staple pockets but they did not form.Replaced by new cartridge and connected the same instrument and the firing were successful.At the same procedure, the customer found a gray plastic piece was attached to the device.They could not identify where this foreign material came from.There was no patient injury.
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.One partially fired single use loading unit (sulu) was received.Additionally, some staples and a staple pusher that had disengaged from the loading unit were received loose in the packaging.No damage was noted to the knife blade.The sulu was loaded into a pmv representative instrument.The sulu and representative device were appli ed to the appropriate test media with acceptable results.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 reported condition may occur if the firing stroke is not complete and the firing knob is not fully retracted after firing or if the instrument is applied against an excessive amount of tissue during the clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
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