As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause could not be established.It is likely the lock lever received extra stress by being pushed to connect to the connector when the user attached the connecting tube.This would cause the lock lever to break off and prevent the connecting tube from being attached.The ifu contains the following statements regarding the connecting tube that may help prevent misuse: "if there is an irregularity of the connecting tube on either endoscope, it must be corrected and both endoscopes must be reprocessed again.Otherwise, the reprocessing of endoscopes may be insufficient." olympus will continue to monitor the field performance of this device.
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