The suspect medical device was not returned to the manufacturer for investigation/evaluation but to the olympus regional repair center (rrc) in hamburg, germany (returned to the rrc on (b)(6) 2022).During the inspection at the rrc, the reported failure of the cutting function could not be confirmed.Thus, the device was evaluated to meet the standard specifications with regard to this issue.However, the hf-generator was found to permanently display error message e433, which was traced back to a defective generator board.Thus, this issue was attributed to component failure.Any error messages that may appear during operation are triggered by the safety system of the esg-400 and communicated visually and acoustically to the user.They are part of the device's own security concept.In particularly critical cases, further use of the device is prevented by the security system until the error has been corrected.A manufacturing and quality control review was performed for the affected serial number of the hf-generator without showing any abnormalities.The case will be closed on olympus side with no further actions.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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