As per a manufacturer incident report we received from the factory in (b)(4): as reported: "due to a sharp edge at the tip of the scope, the bronchus of the patient was ripped upon introduction of the scope, damage to bronchus had to be sutured/repaired" (manufacturer's internal complaint # (b)(4)).
|
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.
|