A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.Based on the results of the investigation, physical or chemical stress was applied to the insertion section during user handling and caused the coating to peel.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: 3.2 inspection of the endoscope.5.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
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