Compared to the predicate device, the current device has a changed design on the device tip.As the tip is chamfered according to specification, the issue was therefore found to be a specification issue and design related.Karl storz decided to recall all affected products - refer to internal fsca reference # (b)(4).None of the devices affected by the recall have been distributed in the u.S.At the time of the occurrence of the adverse event and the initiation of the recall, the device has not been cleared by the fda.This adverse event is now reported retrospectively only because it was requested during fdas review of submission k213194.
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As per a manufacturer incident report we received from the factory in (b)(4): as reported: "prof.Levent cansever said that he was performing a diagnostic mediastinoscopy and conducting a biopsy on tracheal lympe nodes, as a usual procedure for him, while he was pushing forward the blade in mid-line of the trachea, he felt stress on the tissue than he pushed the blade more and the trachea was injured.After this incident, he had to do open surgery for trachea repair." (manufacturer's internal complaint # (b)(4)).
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