This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.Judging from the manufacturing year of the subject device, it was unlikely that the peeling was due to aging deterioration.It was likely that the phenomenon occurred because external force was applied to the relevant part by strongly rubbing it during daily use including reprocessing.The instructions for use (ifu) provides the following guidelines: inspection of the endoscope 3.Inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, forming objects, or other irregularities.
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