This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d9, h3, h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.A definitive root cause was not identified.However, based on the results of the investigation, the probable cause of the malfunction likely includes electrical load or stress on the electrical board in the image sensor and scope connector, static electricity, or overcurrent during connection/disconnection while the system was powered on.These issues may have led to poor electrical connections and unstable image signal output.Additionally, overcurrent could result from other devices or electrical wiring, or from dust and moisture on electrical contacts.The event can be prevented by following the instructions for use which state: instructions, operation manual, chapter 3 ¿preparation and inspection¿, section 3.8 ¿inspection of the endoscopic system¿ was confirmed to describe how to detect the subject event.Olympus will continue to monitor field performance for this device.
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