This report is being submitted to provide 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 2 years since the subject device was manufactured.Based on the results of the investigation it was found that the gas sterilization or sterad sterilization was performed for the endoscope to which foreign objects were adhered, resulting in black residues forming on the distal tip.It was found that the sink for cleaning in the facility was not exclusive to cleaning of the endoscopes.The result of the component analysis showed that the rubber/copper derived components were detected from the above sink used for cleaning the endoscope.A test was performed to verify that black residues on the distal tip were not microorganism contamination.The above components (foreign objects) were adhered to the distal tip of the endoscope while cleaning it.This information is addressed in the instructions for use (ifu): 6.6.2_ labeling review:chapter 1 general policy 1.1 instructions this manual contains the reprocessing methods recommended by olympus for the endoscopes and accessories listed on the front cover.This instruction manual contains essential information on reprocessing endoscopes and accessories safely and effectively.Before reprocessing, thoroughly review this manual and the manuals of the reprocessing equipment and chemicals that will be used for reprocessing.Reprocess all the devices as instructed.Note that the complete instruction manual set for the endoscope and accessories consists of this manual and the ¿operation manual¿ with your endoscope model listed on the cover.Both manuals accompanied the endoscope at shipment.Keep this manual and all related manuals in a safe and accessible location (e.G., in the reprocessing area).If you have any questions or comments about any information in this manual, or if a problem that cannot be solved occurs while reprocessing, contact olympus" olympus will continue to monitor the field performance of this device.
|