Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the olympus local service department on october 29, 2021, it was found that foreign material adhering to the gap of the distal end of the insertion tube of the subject device.Other detailed information was not provided.There was no report of patient injury associated with the event.
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This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) was informed, that it was found, that foreign material adhering to the forceps elevator of the distal end of the insertion tube of the subject device.Device history record review, indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of this event could not be conclusively determined.Omsc surmised, that the reported phenomenon occurred, due to the following cause.- since reprocessing, after procedure by the user was insufficient.Dirt of the forceps elevator was not removed.- since the user, did not conduct reprocessing immediately after procedure.Foreign material on the forceps elevator got dry and adhered there.
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