The scope was returned to olympus for evaluation.A visual inspection was performed and noted the bending section cover was torn and exposing a broken bending section skeleton.Upon removal of the bending section cover, the metal tab was found lifted with sharp edges.The scope was serviced and returned to the user facility.Limited information regarding the event was reported by the user facility as multiple attempts were made via telephone and in writing to gather more detailed information regarding the reported event but with no results.Based on similar reported events and investigation findings, the cause of the protruding / lifting skeleton metal tab 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." if additional information becomes available, this report will be supplemented accordingly.
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