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 the manufacturer for evaluation/investigation but to olympus medical system corporation (omsc), japan (returned to omsc on 2022-11-29).The evaluation at omsc confirmed that the hf-cable was broken at the area of the connector, where the sparks occurred.Age-related wear and tear in connection with a repeated tensile/bending load most likely caused the wires inside the cable to break.When the hf generator is activated, this can result in a voltage flashover in the damaged area.According to the article¿s lot number, the hf cable was manufactured in july 2018.It therefore must be 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 and thus to use error.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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