Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the returned device had a deformed clamping mechanism, staple pushers were flush with the cartridge, and the knife-bar assembly was buckled.It was reported that after firing, the reinforcement material did not release from the device as expected.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the device had been applied on tissue beyond the indicated range.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/or leakage.Always inspect the tissue thickness and select an appropriate staple size prior to application of the stapler.Overly thick or thin tissue may result in unacceptable staple formation.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.If information is provided in the future, a supplemental report will be issued.
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According to the reporter during a pancreatectomy, after firing the device, the buttress material was stuck on the reload after firing and the surgeon needed to use a scalpel to separate the buttress material with the reload.There was no patient harm.Pli10: medtronic's initial evaluation of the incident device found that based on the evidence available the reported condition of tissue stuck on device was confirmed.
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