(b)(4).The endoscope will be evaluated by pentax medical.Once evaluation is completed the device will be repaired and returned to the customer or loaner inventory as applicable.Model eg29-i10 (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On 09-feb-2022, a device history record (dhr) review for model eg29-i10 (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 17-jan-2017 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 for 17-jan-2017.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
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