This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: e1, e2, e3, b5, g2 (unmark other), h6 - component code is being corrected to "424- cap" and h6 - medical device problem code is being corrected to "1091 - device reprocessing problem".Additional information added to field h6, h4, and h3.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation the presumable and definitive cause of the event could not be determined.The event can be prevented by following the instructions for use which state: chapter 6 compatible reprocessing methods and chemical agents."6.5 ethylene oxide gas sterilization conditions.[caution]: attach the sterilization cap to the endoscope before ethylene oxide gas sterilization.If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover.".Olympus will continue to monitor field performance for this device.
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