This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the reported information, it is presumed that the phenomenon, ¿foreign object remained between the distal end and bending section rubber,¿ occurred because the distal end of the bending section rubber was damaged.If additional information becomes available, this report will be supplemented.
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