The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient'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.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 #: wa90300w; brand name: electrosurgical generator "esg-300"; common device name: hf-generators; 510(k): k180200; product code: gei.
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The suspect medical device was returned, to the manufacturer for investigation/evaluation.The evaluation/investigation confirmed, that the returned hf-generator is in standard condition.Furthermore, there were no reports of any malfunction of the hf generator.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined.And is being judged as unknown.However, a material or quality problem can be excluded, since 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.Furthermore, the user will be informed about the investigation results.
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