The scope was returned for evaluation.A visual inspection was performed and noted a cut as well as a sharp metal tab protruding through the bending section cover.Upon removal of the bending section cover, the sharp metal tab was found lifting.The scope was serviced and returned to the user facility.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.Based on the evaluation the user¿s complaint of the scope failing leak check is caused by damage to the broken bending section skeleton due to excessive force which is attributed to mishandling.The scope was purchased on (b)(6) 2015 and the last time the scope came in for service was (b)(6) 2019 for refurbishment.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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