The forceps were returned to pentax europe for evaluation.The evaluation confirmed the cups were deformed as a result of misuse and the broken rings were a result of wear and tear.Pentax europe executed 3 good faith efforts to obtain additional information surrounding the event.No further information was obtained.A replacement was provided to the customer.On 13-dec-2017, a device history review was performed confirming the forceps was manufactured under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.Pentax medical has not received further information for this event and therefore considers this medwatch report closed.
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