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.
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The suspect medical device was not returned to olympus for investigation/evaluation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be conclusively determined.However, the reported failure is a known fault pattern.Wear and tear due to frequent use in connection with repeated great bending and/or tensile loads most likely caused individual or all wires inside the cable to break.When the generator is activated, this can lead to voltage flashovers in the damaged area, which can result in the formation of sparks.According to the article¿s lot number, the hf cable was manufactured in october 2018.It is therefore assumed that the hf cable was used longer than the 12 months the cable is designed for.Thus, this event/incident can most likely be attributed to age-related wear and tear in connection with improper handling by the customer.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.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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