The device was returned for investigation.Upon evaluation of the device, biopsy channel leak was confirmed.In addition, scrape mark inside boroscope, insertion tube deep dent, bending section cover crack, and distal end plastic cover dent were noted.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur olympus will continue to monitor complaints for this device.
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