The suspect medical device was not returned to the manufacturer for evaluation/investigation since it was reportedly discarded.Therefore, the evaluation was performed exclusively on the basis of the available information.Therefore, the cause of the reported event could not be conclusively determined.The reported issue is a known fault pattern which was evaluated as plausible.It is assumed that wear and tear in connection with a repeated tensile/bending load caused single or all wires inside the cable to break.According to the article¿s lot number, the hf cable was manufactured in may 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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