This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from olympus (b)(4) there was the possibility that the reported phenomenon was attributed to the temporary malfunction due to the aged deterioration of the video output driver on the video circuit board.
|
Olympus medical systems corp.(omsc) was informed that during the preparation for use, the image of the subject device blinked green and pink.The user cycled the power of the device, the issue was resolved.The field staff of olympus (b)(4) checked the device at the user facility and found that the reported phenomenon was duplicated, but the user facility wished to continue using the device without repair.There was no report of patient injury associated with the event.
|