There was no device returned to olympus for evaluation/investigation.Therefore, the exact cause of the patients' outcomes and the reported phenomenon could not be determined and is being judged as unknown.The case will be closed from olympus side with no further actions but may be reopened if a device is returned for evaluation/investigation or additional significant information becomes available at a later time.Then, this report will be updated.Furthermore, the reported events/incidents will be recorded for trending and surveillance purposes.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 #: wa29042a; brand name: ureteroscope, 8,6/9,8 fr.X 430 mm, 7°, 6,4 fr.Channel, with wa00396a; common device name: ureteroscopes, autoclavable; 510(k): k951855; product code: fgb.
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