The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience 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.Please note: the report id for the first report was 9610773-2022-00173.
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The suspect medical device was returned to the manufacturer for investigation / evaluation.The investigation did not reveal any anomalies, malfunctions or defects.The hf-cable was found to be working as intended and rated as meeting its specification.Based on the information available, the exact cause of the reported phenomenon and the user¿s experience could not be determined and is being judged as unknown.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf-cable without showing any abnormalities, non-conformities or deviations regarding the described issue.However, according to the article¿s lot number, the hf-cable was manufactured in february 2020 and thus most likely has already exceeded its service life and should no longer be used.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
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