The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, it was discovered that the foot switch was not functioning properly due to a faulty printed circuit board.If additional information becomes available following the device evaluation, a supplemental report will be filed.
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The customer reported that his olympus hf generator unit began presenting e155, e006, & e022 error codes during procedure preparation.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.
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