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 11 years since the subject device was manufactured.Based on the results of the investigation, olympus confirmed the suggested event.The issue could have occurred due to stress of repeated use, external factors or handling of the device, the image sensor unit was damaged such as disconnection or a part mounted on the electrical circuit board such as integrated circuit chips and capacitors was broken which may have resulted in the subject event.However, the root cause could not be specified.The event can be prevented and detected by following the instructions, operation manual, chapter 3 ¿preparation and inspection¿, section 3.8 ¿inspection of the endoscopic system¿ which describes the methods for handling on the suggested event olympus will continue to monitor field performance for this device.
|