Evaluation summary: 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 an articulating vascular/medium reload.During testing of the instruments, a skip was noted in the units firing stroke after closure of the reload jaws.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 release 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: 1.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 would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
|
According to the reporter, occurred during a laparoscopic lobectomy procedure.The stapling device was being used during clipping.When using the fifth reload, the stapler did not work.The surgeon pressed the green button but the stapler was not armed for the firing.The trigger did not advance.It was hard and after being forced, it gave a strong snap and was left with a soft trigger.The stapler was able to fire.In order to resolve the issue and complete the case, the surgeon opened a new manual stapling handle.There was no patient harm.Reinforcement material was used.
|