Post market vigilance (pmv) led an evaluation of one device.Initial visual inspection of the instrument noted no abnormalities.Functionally, the instrument was loaded with a representative reload.During the firing cycle, a skip was audible in the firing stroke.An access hole was cut into the instrument body for visualization of the firing rack.This examination noted sheared teeth on the firing rack.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality rel ease specifications at the time of manufacture.Replication of the sheared teeth on the firing rack 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.In either of these circumstances, 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 information booklet which accompanies each product shipment offers the following as a warning and precaution."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.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
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