Olympus medical system corp.(omsc) was informed that at the time the user facility started f-tul procedure and treatment, no image and image difficulties broke out.The user facility operated the monitor, but the image was not improved.Since the user facility did not have a backup scope, the procedure was aborted.There was no patient harm reported.
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The subject device was returned to omsc for evaluation.Evaluation confirmed the reported phenomenon of no image and image difficulties as the video-connector was moved slightly.No air leak was detected and no irregularities of outer appearance were found in the video-connector and video-connector substrate.And also, no irregularities were found in soldering of the video-connector, electrical connection, wiring, surface of electrical cables and resistivity.As electrical connection was changed to connect the video-connector to a different substrate, the image became normal.As a result of the evaluation, omsc concluded that there was a breakage of the video-connector substrate.The manufacturing history was reviewed, with no irregularities related to this problem noted.This report is being submitted as a medical device report in an abundance of caution.
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