The suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center found, the bending section cover was also cracked and peeling.The control body, scope connector and other connectors showed fluid invasion and corrosion.The elevator channel is detached and leaking.It was also noted the fluid invasion impacting the image, along with multiple consecutive broken elements.The faulty parts were replaced.The device was inspected and passed olympus functional standards.A definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the cause of the forceps cover glue peeling likely occurred due to an external force applied to the part.Investigation confirmed that there was no adhesive in the position where adhesive should have been applied.The cause of the bending section cover detaching likely occurred due to an external force applied to the part.The specific root cause of the external force could not be determined at this time.The following information is stated in the instructions for use: "3.2 inspection of the endoscope.5.Inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, peeling, scratches, holes, sagging, transformation, bends, adhesion of foreign body, detached, parts, protruding objects, or any other irregularities." olympus will continue to monitor field performance for this device.
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