During inspection and testing, foreign material was found stuck in the biopsy channel.A review of the device history record found no deviations that could have caused or contributed to the foreign material being present.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, since there was an air leak from the universal cord, it was presumed that foreign materials remained in the instrument channel due to incorrect reprocessing.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.In addition, the device leaked due to the universal cord being damaged, the adhesive on the bending section cover was separated due to deterioration, forceps could not be inserted due the foreign material clogging the channel, and the cable tube unit was scratched.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.
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The customer reported that, following a procedure, the subject device leaked and the bowden cable was found to be defective.The subject device was sent to an olympus service center for evaluation.During inspection and testing, foreign material was found stuck in the biopsy channel.This report is being submitted for the malfunction found during evaluation (foreign material).There was no harm or user injury reported due to the event.
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