Olympus checked the subject device and concomitant devices (the video processor otv-s7v and the camera head otv-s7h) at the user facility, and there was no abnormality in these devices.After that, the subject device was returned to olympus, and olympus confirmed the subject device worked properly.The user facility already sent the telescope and the light guide cable used in the procedure to smith & nephew.So olympus could not check the subject device connected with the telescope and the light guide cable.A tip of a telescope becomes hot during turning on the examination lamp of this device.The facility placed the tip of the telescope on the medical drapes while the subject device turned on, so the patient might get burned because the hot tip of the telescope touched the patient's skin via the medical drapes.Olympus also checked the device history record of the subject device, and there was no irregularity found.The instruction manual of this device already mentions cautions for a telescope and a light guide cable handling during turning on the examination lamp of this device.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.
|