A user facility returned to olympus for repair a scope that failed the leak test in their medivator.The problem, as reported to olympus, was found during reprocessing.Upon evaluation of the returned device, it was noted that the forceps cover glue was peeling.There was no patient injury or harm, associated with the problems, reported to olympus.
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This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.The instructions for use states: ultrasound gastrovideoscope gf-uct180.Chapter 3 preparation and inspection.3.2 inspection of the endoscope.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, protruding objects, or other irregularities.
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