The olympus asset device, high flow insufflation unit, was sent to the olympus service center.Upon inspection and testing of the returned device, it was discovered there was a missing power switch and a damaged top cover.There was no patient involvement.The medical device report (mdr) is being submitted to capture the reportable malfunction of the power switch failure found during evaluation.
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The asset device was returned to olympus.Upon inspection testing of the returned device, the missing power switch and damaged top cover were replaced.In addition, there was notable damage to the front panel screw receptacle.The review of the device history record (dhr) did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The investigation could not identify the cause of the missing power switch.No fault was confirmed after the troubleshooting the device.The instructions for use cautions the user on the handling of the device to prevent this type of failure: ¿hitting the equipment with an object or handling it violently may cause malfunction.Always handle the equipment carefully.¿ investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.Olympus will continue to monitor the field performance of this device.
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