The device was returned to olympus for evaluation.The customer¿s reported angulation issue was confirmed.A visual inspection was performed on the returned device and found critical defects to the scope¿s distal end cover, bending section glue, bending section and light/image bundle.The angulation function of the scope was found to be abnormal.Further evaluation noted restrictions when attempting to insert test instruments into the scope¿s forcep and brush passage.The device has been repaired and returned to the customer.As a preventive measure, the scope operation manual has pre-procedure instructions for inspecting the scope, including inspecting the bending section for deformation, and functional verification of the angulation.The operation manual states that during the procedure, if the angulation malfunctions, ¿stop the procedure immediately and place the up/down angulation lock in the free ¿f ¿ position.Then carefully withdraw the endoscope while observing the endoscopic image.If the endoscope cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it.Rather, withdraw the endoscope carefully.If the endoscope cannot be withdrawn from the patient, consider removing it through open surgery and take proper measures.¿ and ¿do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.¿ the operation manual also recommends ¿be sure to prepare another endoscope to avoid interruption of the examination due to equipment failure or malfunction.¿.
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