There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.X-smart head assembly, sav various mechanical problem, corroded.X-smart head cap, sav bad maintenance (user).There is some rust on the head cap.X-smart neck, sav other, rotation not fluid.X-smart cartridge, sav other, file does not fit.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
|