There is no additional information available for this event as yet.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned but the actual device evaluation is not completed.An evaluation from historical data is available and included here.The device history review confirmed that device there were no abnormalities, special adoption, or variations in manufacturing.The device shipping was under normal conditions.The device cap was left open during reprocessing is the likely cause of the issue.Instructions for use include statement: for eog sterilization: attach the sterilization cap to the endoscope before ethylene oxide gas sterilization.If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism.) for ethylene oxide gas sterilization: attach the sterilization cap to the endoscope before ethylene oxide gas sterilization.If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism.Device evaluation is not yet completed.
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