This supplemental report is being submitted to provide the evaluation and legal manufacturer investigation.Please see the updates to the following sections: d10, g4, g7, h2, h3, h6, and h10.The device was returned to the service center for evaluation.Cuts were noted on the insertion tube causing a leak to be observed.Minor scratches were noted on the scope¿s light guide lens.The bending section glue was noted to be cracked.The bending section charge-coupled device (ccd) shrink tube was found cut and cracked.The scope¿s id chip showed 950 total uses.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.As a result of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: there is a possibility that the bending tube was damaged and metal protruded because some external force was applied to the bending section.The subject product was manufactured on november 8, 2016 and about 4 years and 3 months have passed, and it is unknown whether it was affected by aging deterioration.The legal manufacturer confirmation of contents described in the instruction manual> cyf-vh/vhr/vha operation manual chapter 3 preparation and inspection 3.3 inspection of the endoscope.4 inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.5 holding the control section with one hand, carefully run your other hand back and forth over the entire length of the insertion section.Confirm that no objects or metallic wire protrude from the insertion section.Also, confirm that the insertion tube is not abnormally rigid.6 using both hands, bend the insertion tube of the endoscope into a semicircle.Then, moving your hands as shown by the arrows in figure 3.4, confirm that the entire insertion tube can be smoothly bent to form a semicircle and that the insertion tube is pliable.7 gently hold the vicinity of the distal end and a point 10 cm from the distal end.Push and pull gently to confirm that the junction between the bending section and the insertion tube is not loose.
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