This supplemental report is being submitted to provide the correction of the initial mdr and the legal manufacturer's final investigation.Corrected fields: b5 additional information: 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 ten (10) 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 "foreign material in the nozzle¿" malfunction would likely be related to a dent in the nozzle.The event can be prevented by following the instructions for use which state: ifu states the detection method in ¿evis lucera gif/cf/pcf type 260 series operation manual chapter 3 preparation and inspection¿.Ifu states the preventive measures in ¿evis lucera gif/cf/pcf/sif type 260 series reprocessing manual chapter 3 cleaning, disinfection, and sterilization procedures¿.Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer.Olympus will continue to monitor field performance for this device.
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