The scope is in use at the facility.The subject device was not returned to the service center for evaluation.The cause of the improper reprocessing cannot be determined at this time.As part of our investigation, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary.To date, the ess visit has not been finalized.In addition, the customer was provided the delayed scope reprocessing letter via email.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.
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This report is being supplemented to provide additional information based on 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 4 years since the subject device was manufactured.Based on the results of the investigation, the cause is likely human error.This issue is addressed in the instructions for use (ifu): "oes cystonephrofiberscope cyf-5/cyf-5a chapter 7 cleaning, disinfection and sterilization procedures 7.3 precleaning preclean the endoscope at the bedside in the procedure room immediately following the procedure.When using the cyf-5, these steps are to be performed when the light source is turned off.When using the cyf-5a, the steps are to be performed when the suction pump is turned on and still connected to the endoscope.If the endoscope is not immediately precleaned, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope." olympus will continue to monitor the field performance of this device.
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