This supplemental report is being submitted to provide the results of the device evaluation, the legal manufacturer¿s investigation and the device history record (dhr) review.New information was added to the following fields: h3, h6, h10.Inspection of the returned device found chipping of the bending section cover glue as well as cutting and crushing of the insertion tube.The insertion tube boot and the boot of the control section side were scratched.In addition, the bending angle was insufficient, the angle wires were stretched, and a whitish color of the objective lens glue was noted.The dhr for this device was reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The following deviations of reprocessing methods from the instructions for use (ifu) were confirmed: ·manual cleaning was not performed while the endoscope was immersed into detergent solution.·the forceps elevator was not raised/lowered three times while the endoscope was immersed into detergent solution.·detergent solution was not supplied into the forceps elevator.·water filter of the automated endoscope reprocessor was not replaced within the specified period.·as a result of checking the subject device, any irregularity such as air leak, scratches inside the channel, or stain were not confirmed.A definitive root cause was not identified.Based on the available information, the legal manufacturer could not determine the relationship between the subject device and infection.Detailed information about the infected patients was unable to be determined, and the result of the culture test of the subject device was negative.The ifu states the following: if the endoscope is not cleaned meticulously, effective disinfection or sterilization may not be possible.Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms or organic material that could reduce the efficacy of disinfection or sterilization.Olympus will continue to monitor the field performance of the device.
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