Pentax medical was made aware of a complaint which occurred in the united states.The customer reported there was an "intermittent flickering image" involving pentax medical ultrasound video gastroscope, model eg38-j10ut, serial number (b)(4).The timing and location of the issue observed are unknown.There was no report of death, serious injury or any event requiring medical intervention.
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This model is classified as import for export and not distributed in the united states, therefore 510k is not applicable.We do have similar model eg38-j10ut-us available in the united states with a 510k number k200090.(b)(4).The customer owned endoscope was assigned rma (b)(4) but has not been received by pentax medical for evaluation as of 23-nov-2021.Model eg38-j10ut, serial number (b)(4) has not been previously returned for serviced at a pentax facility since the device was put into service.On (b)(6) 2021, a device history record(dhr) review for model eg38-j10ut, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 18-oct-2019 under normal conditions, passed at the second inspection for replacement of udi-plate, 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 18-oct-2019.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
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