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 9 years since the subject device was manufactured.Based on the results of the investigation, it is presumed that the event may occur when physical stress, such as hitting/dropping or chemical stress is applied to distal end.However, a definitive root cause could not be determined.The event can be detected by following the instructions for use: operation manual_ inspection of the endoscope inspect the objective lens and light guide lens at the distal end of the endoscope for scratching, cracks, stains, gaps around the lens, or other irregularities.The event can be prevented by following the instructions for use: operation manual_ important information ¿ please read before use warning: do not strike, hit, or drop the endoscope¿s distal end, rigid portion, bending section, control section, universal cord, video connectors, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, rigid portion, bending section, control section, universal cord, video connectors, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.Reprocessing manual_ compatible reprocessing methods and chemical agents_ compatibility summary precaution methods listed as ¿compatible¿ in table 3.1 and 3.2 are compatible for routine use only when used according to manufacturer¿s instructions.Repeated use and reprocessing of endoscopes and accessories lead to gradual wear and tear.Furthermore, reprocessing methods that employ higher temperatures and more caustic/corrosive materials may lead to faster deterioration.In general, sterilization processes are harsher on equipment than disinfection processes.Before each patient procedure, inspect the endoscope and accessories for damage, according to the instructions described in this manual and its companion ¿operation manual¿.Olympus will continue to monitor field performance for this device.
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