This supplemental report is being submitted to provide the results of the device evaluation and 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.It has been over nine (9) years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the investigation results, it was found that during the use of an endo therapy accessory for high-frequency cauterization, leaked current flowed through the patient via the light guide lens end of the device, causing the flow of high-frequency current in the patient.From the investigation it is presume that the deterioration of the glue filled between the distal end and the plastic distal end cover/probe cover led to poor insulation performance.The event can be prevented by following the instructions for use which state: "-operation manual 3.2 inspection of the endoscope 9.Inspect the objective lens and light guide lens at the distal end of the endoscope¿s insertion section for scratches, cracks, stains, gaps around the lens, or other irregularities." olympus will continue to monitor field performance for this device.
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