The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: the halar coating of the shaft serving as an insulation has become hardened due to frequent reprocessing and shows indentations or cuts.Also, there are short-circuit marks in the distal area.Also, the instrument¿s marking is deteriorated, and the blue color ring is faded.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, the reported issue is attributed to customer error and customer infrastructure.The customer used a damaged or worn instrument by not following the directions provided in the instructions for use (ifu).The shaft shows clear and severe signs of wear and tear in all its areas.Also, the product is designed for 400x reprocessing cycles.Therefore, the expected service life must be considered as considerably exceeded.This supplemental report includes a correction to the following fields: a1, b3, d9, e1, e2, e3, g2, h6 and h8.Additional information has been added to d4, d8 and h4.Also, an update has been made to h3 from the initial medwatch.Olympus will continue to monitor field performance for this device.
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