The suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus shanghai (osh)/china (returned to osh on (b)(6) 2022).Even though the evaluation could not reproduce the occurrence of error message e433, it was shown in the hf generator¿s error log.Error message e433 is triggered by the generator¿s safety system and can have different technical causes.In case of critical errors, the safety system will not permit any further use of the generator until the error is rectified.In the case at hand, the error message could not be reproduced.Thus, a temporary fault is assumed and the exact cause for the occurrence of the error message could not be determined in this case.In addition, the relay board and the front panel were found to be not correctly fixed.This was most likely caused by either an improperly performed service activity or an unauthorized third-party manipulation.However, these defects are not related to the occurrence of the reported error message.Also, 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, but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.Please note: this report is being submitted although the suspect medical device is not marketed in the usa.However, a similar device is marketed.Model # / catalog #: wb91051w; brand name: electrosurgical generator "esg-400"; common device name: hf-generators; 510(k): k203682; product code: gei.
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