The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the consultant'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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Additional information: d4 ¿ lot number, h4 ¿ device manufacturer date device evaluation: the suspect medical device was returned to the manufacturer for investigation/evaluation.The investigation confirmed that the hf cable is broken.The damage found is a known fault pattern.Age-related wear and tear 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 resulted in the formation of sparks and the complete severing of the wires/the connector.According to the article¿s lot number, the hf cable was manufactured in may 2017.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 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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