Pentax medical was made aware of an event which occurred in the pai region involving pentax video ultrasound scope eg36-j10ur-us.In the event reported, it was stated that there was no ultrasound image.The timing of this anomaly is not known.There was no adverse event reported with this complaint.The device was returned to pentax medical on service order (b)(4) and is pending evaluation.A review of the service history indicates the device was not routinely serviced at a pentax facility.On 26-aug-2021, a device history record (dhr) review for model eg36-j10ur, serial number (b)(4) was performed and the dhr review confirmed the endoscope had 1 non-conformance found during in-process inspection for image defect.The objective lens was reworked, and the device completed manufacturing on 20aug2020 under normal conditions, passed all required inspections, and was released accordingly.The dates of approval for shipment and actual date shipped were confirmed.
|
This device is classified as import for export, therefore 510k is not applicable.Similar model eg36-j10ur-us is available in the usa with a 510k number k200090.(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
|