After the customer reported her damaged device to olympus, olympus dispatched a field service engineer (fse) to the user facility.While at the facility, the fse repaired the subject device according to oem instructions.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and a correction to d9.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, it is likely the connector could not be connected as some impact was added to the connector and the connector became loose and came apart.Probable causes for the event include: -accumulated stress over time which caused the connector to get loose -unintentional impact to the connector with something hard.We could not confirm any factor from the design nor structure of the device that would cause the reported event.The cause of the reported event cannot be conclusively determined.Per the instructions for use: ¿check the following for each connector.The connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.¿ and ¿warning -do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral device or facilities near the equipment.¿ olympus will continue to monitor field performance for this device.
|