It was reported to olympus that a gastroinstestinal videoscope had bending manipulation and insertion tube defects (loose wheel).The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: control knob movement, low tension.There was no patient injury or adverse event reported to olympus.
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The device was returned to olympus for evaluation and repair.During the evaluation, the returned device was inspected.The labels were peeling and part of upmark was missing.The instrument channel had a leak.The angulation and tension were found low.The plastic had dents and scratches.The objective lens and light guide lens had the glue peeled.In addition, the rubber glue was cracked, the insertion tube had a dent and the control body had scratches and dents and missing the red ring.Lastly, the scope connector had scratches on the plug unit.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.Olympus will continue to monitor the field performance of this device.
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