It was reported that the high flow insufflation unit exhibited wetness, did not switch on, and the display did not light due to a defective power supply board and front panel respectively.The event was found during preparation for use for an unknown procedure.There were no reports of patient involvement.
|
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: g2 (company representative should be blank in the initial medwatch).Additional information added to field h3, h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, the power of the device cannot be turned on, likely due to the failure of the power board, and the display is not lit, likely due to the failure of the front panel.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
|