The device was returned to olympus for evaluation, and it was uncovered that the nozzle was clogged by unidentified, white-colored foreign material.The foreign residue resembled a cleaning agent that could not be removed.This finding was due to insufficient cleaning or handling of the scope.Upon further inspection, it was observed that the rubber of switch button one is pierced and leaky.It was also observed that the charge-coupled device cover lens was chipped.It was observed that the acoustic lens of the probe unit had cuts.Additionally, it was observed that the piezo elements of the probe unit were defective.It was also observed that the control unit¿s scope body was damaged.It was observed that the universal cord was kinked.Lastly, it was observed that the insulation value at the distal end was out of specification.This report is also being submitted to provide additional information based on the legal manufacturer's final investigation.Section b5, d8, d9, and h3 were updated with additional information that was received about the event.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 definitive root cause of the foreign material could not be identified.Considerations ¿
1) during a follow-up with the customer, the customer confirmed that the facility followed the instructions manual and the national regulations however, no information or reprocessing observations were conducted to confirm if the reprocessing methods were carried out properly.2) upon inspection from the repair department, there was no abnormality on the device at the nozzle.Olympus will continue to monitor field performance for this device.
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