It was reported in arthroscopy: the journal of arthroscopic & related surgery [2014;30(8):957-963], "hip arthroscopy for femoroacetabular impingement: the changing nature and severity of associated complications over time", the tip of a flexible rf probe (vulcan ablator) broke.Journal article notes, "all broken surgical instruments were successfully removed, except a tip from a broken rf probe.However, this patient did not show any pain or mechanical symptoms attributable to the broken tip nor was the piece visible on radiography (p 1/4.045).".
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Device investigation narrative - visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.No further investigation is required.(b)(4).
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