The scope was returned to olympus for evaluation.A visual inspection was performed and confirmed the bending section cover was missing.In addition, the bending section skeleton section tab was fully broken and detached, however, there was no sharp areas noted with the broken and detached bending section skeleton.A review of the scope¿s instrument history showed the scope was purchased on (b)(6) 2015 with no previous repair records.The scope was serviced and returned to the user facility.Based on similar reported complaints and investigation findings, the most probable cause of the broken /sharp 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 angulations control lever does not move.If the angulations 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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