The scope was returned to the manufacturer for service/evaluation.A visual inspection was performed by the service group and noted the bending section at the distal end of the scope was broken and the bending section skeleton was protruding.The scope failed the leak test from the hole on the bending section cover.In addition, there were excessive broken image guide fibers noted on the image.The scope was last serviced on (b)(6) 2019.The scope was repaired and returned to the user facility.Based on the reported condition and the analysis of the device, the cause of the broken bending section skeleton and broken fibers is most likely due to excessive force and/or stress attributed to user mishandling attributed to the (unintended) operator's technique.The instruction manual warns users "do not twist or bend the bending section with your hands.Equipment damage may result; do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged." 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." based on the reported condition and the analysis of the device, the cause of the broken bending section skeleton is most likely due to excessive force and/or stress attributed to user mishandling.If additional information becomes available a supplemental report will be filed.
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