Corrected g2: health professional was inadvertently selected on the initial medwatch.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned, and an evaluation was completed.During inspection, olympus found connecting tube has coating peeling (1mmsq or more).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 were identified.Based on the results of the investigation, it is likely physical stress caused the coating to peel.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): 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 field performance for this device.
|