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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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X-smart head cap, bad maintenance (user), there is some rust on the head cap.X-smart neck, other, rotation not fluid.X-smart cartridge, various mechanical problem, rotation not fluid.Replaced 1 x x cartridge h1004c5210150, 1 x x head cap h1004c5210500 and 1 x x neck h1004c5470220.
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