It was reported that there was an intraoperative issue with the vascular clamps.During an attempted partial nephrectomy, as the clamp was being used on the renal artery, it was noted that it was not "strong" enough and not applying enough pressure.The procedure was changed to a radical nephrectomy due in part to the malfunction.There was no additional information provided.There was no surgical delay.Associated medwatches: 9610612-2019-00320 (this report - 2nd clamp), 9610612-2019-00319.
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Associated medwatches: 9610612-2019-00320 (this report - 2nd clamp) and 9610612-2019-00319.Concomitant parts reported separately - insulated outer tube x 2 and axial ring handle only ratchet/lock.H4 - manufacture date: 01jun2017.Manufacturing site evaluation: both clamps returned were short jaws and not one short and one long, as initially reported.Concomitant devices (involved components) returned were insulated outer tubes x2 and optional handles for customizing instruments both with a ratchet lock on the handle.Investigation - the instruments arrived in a good condition, and no deviations could be found with the naked eye.The devices are according to the specifications valid at the time of production; based on drawings, "the clamp must not close when jaws are closed" to ensure proper function during application.Batch history review - a review is not possible because the lot number is unknown.Conclusion and root cause - based on the information available as well as a result of our investigation the root cause of the failure is most likely related to an insufficient usage.Rationale - according to the responsible quality coordinator of the production plant, the provided instruments were according to specifications.Therefore, it appears to be a usage related error, e.G.Too much tissue between the jaws during application.A capa is not necessary.
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