The scope was returned to olympus for evaluation.The evaluation confirmed the reported device issue.The bending section was found completely broken/detached near the insertion tube area of the scope.In addition, there was a leak found between the control body and metallic ring at the distal end side of the scope.The scope was serviced and returned to the user facility.Based on similar reported events and investigation findings, the cause of the reported device issue could be attributed to the operator¿s technique.The original equipment manufacturer (oem) performed investigations related to this device issue.As a result, the oem has conducted a field corrective action including a distribution of ¿instructions for safe use¿ to mitigate the potential risk of patient injury.The ¿instructions for safe use¿ provides several warning statements in an effort to prevent equipment damage and patient injury.¿if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient.If the up/down angulation control lever does not move.If the angulation control mechanism is not functioning properly.Visually inspect the bending section for no metallic parts protruding from the bending section.Visually inspect the bending section for bends, twist, or other irregularities while the bending section remains straight.Visually inspect the bending section for abnormal bending shape, or other irregularities.Continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation.".
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