According to the reporter, during the laparoscopic distal splenopancreasectomy, when on pancreas resection, the stapler unexpectedly stopped firing and did not work anymore.It was also mentioned that the jaws of the device locked on tissue.The surgeon had to reset the powered stapler by pressing and holding the two small green button for some seconds since the device was completely blocked.When the powered stapler started to work again, the surgeon immediately changed the reload to fix the staple line and completed the resection of the pancreas.There was no patient injury.
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D10 concomitant products: sigadaptstnd, sig power sigadaptstnd linear adapter, (sn #: (b)(6)) sigpshell, sig power sigpshell control shell, (lot #n3j1787y) sigtrsb60axt, sigtrsb60axt 60mm xtr thk reinforced rel, (lot #n1g0451y).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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