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 21 cfr part 803.After inspection found cartridge lock broken and head cap weak, replaced cartridge and head cap.
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(b)(6), as per customer: file not getting lock.As per service engineer: h1004c5210150: broken, h1004c5210500: weak, under warranty invoice no.(b)(4) dated 22-09-2021.There was no injury to patient investigation result: cartridge lock broken, head cap weak, replaced cartridge, head cap received = 1x x-smart cartridge h1004c5210150 1x x-smart head cap h1004c5210500.X-smart cartridge sav various mechanical problem the files could not be well fixed.
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