The device was returned for evaluation and the customers allegation could not be confirmed.No external abnormalities were found.The sheath, electrode, and reflux sheath were all assembled, and no abnormalities were found.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
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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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