The patients experienced consecutive urethral strictures after transurethral resection in saline (turis) procedures in which the working element (wa22366a) and 24fr resection sheath (a22041a) were used in combination.The procedure was completed using the same device and no additional medical treatment or surgical intervention was required.The physician opinion is that either the handle or the sheath was the cause.Related patient identifiers: (b)(6) working element, active, for resection in saline (wa22366a / 147w0080).(b)(6) working element, active, for resection in saline (wa22366a / 147w0080).(b)(6) resection sheath, 24 fr.(a22041a / 147w0083).(b)(6) resection sheath, 24 fr.(a22041a / 147w0083).This medwatch is for patient identifier (b)(6).
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, since the subject device was not returned to olympus for evaluation, the root cause of the reported event could not be determined.This supplemental report includes a correction to d9 and h3 from the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.
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