According to the reporter, during a laparoscopic right upper lobectomy and wedge resection, during lung resection across the parenchyma, while using the first handle with a black 60mm reload, the surgeon tried to staple but found out that it was extremely difficult to staple the tissue.The green button was unable to be pressed.The second reload did not lock and the gun was unusable.A second handle was used but the same issue occurred.A new stapler from a different manufacturer was used to resolve the issue.No patient injury.Medtronic's initial evaluation of the incident is that the sheared teeth were visible on the firing rack at site of initial firing post clamp up.
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D10 concomitant products: egiaustnd, egiaustnd endogia ultra univ std stap (lot#p3d0429); unknown egia su, unknown endo gia sulu (lot#unknown); unknown egia su, unknown endo gia sulu (lot#unknown) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the instrument firing knobs were retracted.The articulation lever was in neutral position.Functionally, the instrument was successfully loaded with a representative single use loading unit.The instrument loaded, clamped, yet would not cycle due to the sheared firing rack teeth damage.An access hole was cut into the instrument body for visualization of the firing rack.Sheared teeth were visible on the firing rack at site of initial firing post clamp up.It was reported that the instrument was difficult to load.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: sheared teeth on the firing rack.The product analysis noted evidence that the device was not used as intended.This issue may occur in any of the following circumstances: firing over tissue that is beyond the recommended thickness range.Firing with an obstacle incorporated in the jaws.Attempting to fire a reload that is in interlock.In each circumstance, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract.In addition, staples may not form properly, and tissue may not be fully transected.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: preoperative radiotherapy may result in changes to tissue.These changes may, for example, cause the tissue thickness to exceed the indicated range thickness for the staple size.Careful consideration should be given to any pre-surgical treatment the patient may have undergone and in corresponding selection of staple size.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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