The scope was returned to olympus for evaluation.The evaluation confirmed the reported device damage.The skeleton was found broken and exposed/protruding from the bending section cover; however, the distal end cover was still intact.The scope failed leak testing due to a cut on the bending section cover.In addition, the bending section cover was removed and found the bending section skeleton broken below the insertion tube.The device was serviced and returned to the user facility.The cause of the broken skeleton could not be determined; however, this type of bending section damage is attributed to excessive force.The instruction manual for use states, "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿.
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