This supplemental report is being submitted to provide the results of 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.It has been over 6 years since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction suction does not stop was not confirmed.Based on the results of the investigation, a definitive root cause for the event could not be determined.However, it is likely that the automated suction function may have been activated by pushing the patient's abdomen or by continuing overpressure at or above the set 5mmhg for more than 10 seconds due to coupling with the respiratory organ.In uhi-3 instructions for use, 21st edition, p.43, there is a description of the automated suction function."when the abdominal pressure exceeds 5mmhg for the set pressure, the abdominal overpressure warning light is turned on and a warning sound is generated, and if this condition lasts for more than 10 seconds, automated suctioning is performed until the abdominal pressure falls to the set pressure.Foot switch operation is described below on page 45."for safety, when the abdominal pressure is below 3mmhg, when the insufflation mode is low, and when the insufflation is stopped, smoke evacuation does not operate even when the foot is switched.(smoke evacuation does not operate even when the pneumoperitoneum tube is not connected to the patient by inspection, etc.)." olympus will continue to monitor field performance for this device.
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