The device was returned to olympus for evaluation where service confirmed the customer's complaint was due to a faulty main circuit board.The device was repaired and returned to the customer.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 investigation, the cause of the internal circuit malfunction is likely due to the failure of the pressure sensor mounted on the main board.The cause of the failure of the pressure sensor mounted on the main board is like due to any of the following process errors: oxygen entered the device and the electrode of the pressure sensor was oxidized and corroded.The wiring inside the pressure sensor was peeled off due to the oxidation corrosion.Foreign matter (epoxy) had adhered to the mounting of the component due to a mistake, the wires inside the pressure-sensor had peeled off due to adherence of the foreign matter.The following is stated in chapter 7.1 of the instructions for use and can detect the event: "how to distinguish abnormal causes and how to cope with them.Details of the error: all leds are off; cause: an error has been detected in the internal circuit of this product." this mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
|