The customer reported that her olympus high flow insufflation unit shutdown during a laparoscopic vaginal hysteroscopy.According to the initial reporter, the staff restarted the subject device but ultimately had to complete the procedure using another unit with 30 minute delay, and no patient harm.
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The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user's report could not be duplicated.However, the customer did provide a video of the reported failure.Evaluators deduced that the reported failure was likely caused by a damaged main printed circuit board, and that board will require replacing.If additional information becomes available following the device evaluation, a supplemental report will be filed.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the phenomenon was duplicated, and it pointed out that the phenomenon was caused by faulty main board.There was no description for the cause of the defect.Olympus will continue to monitor field performance for this device.
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