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 3 years since the subject device was manufactured.The device was not returned to olympus for inspection.However, it was confirmed that reprocessing had been performed without attaching maj-2358.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the user did not thoroughly read the instruction manual, and reprocessing had been performed without attaching a connecting tube.The event can be [detected/prevented] by following the instructions for use: instructions for oer-5, oeration manual.Section 4.7 ¿connecting tube installation¿ to find out what connecting tubes can be used, refer to the provided ¿list of compatible endoscopes/connecting tubes ¿.Warning attach all of the connecting tubes specified according to the type of the endoscope.If reprocessing is performed without attaching all of the required connecting tubes, reprocessing may be ineffective.Although the ¿list of compatible endoscopes/connecting tubes ¿ shows the applicable connecting tubes for each endoscope, it may not list the latest endoscope models.If your endoscope model is not listed, contact olympus for more information." olympus will continue to monitor field performance for this device. .
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