The actual device is not available for evaluation.Evaluation is performed with communication and historical records.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria at the time of shipping.In an in-service performed at the facility for the device, the olympus endoscopy support specialist (ess) noted that the customer did not follow the recommendations for reprocessing as described in the reprocessing manual for the device.Based on the observations, ess has made the following recommendations to the customer, so that reprocessing at the facility is aligned with the instructions for use (ifu): ess demonstrated proper reprocessing steps beginning with bedside pre-cleaning through high level disinfection to the facility staff.Ess recommended that the customer purchase a leak tester as soon as possible and that the customer purchase the appropriate size basin for reprocessing and the appropriate cleaning brushes.Ess recommends that the scope be stored in a well ventilated cabinet or container after reprocessing.Ess recommended a follow up in-service.It is verified that the ifu includes: -recommendation for performing a leak test after cleaning the bedside in order to secure watertightness of an endoscope.(reference: chapter 7 cleaning, disinfection and sterilization procedures_7.4 leakage testing) -bw-15b and mh-507 recommended cleaning brushes.(reference: chapter 7 cleaning, disinfection and sterilization procedures_7.1 required reprocessing equipment) -recommended cleaning, sterilizing, and disinfecting reusable parts.(reference: chapter 7 cleaning, disinfection and sterilization procedures_7.9 cleaning, disinfection, and sterilization procedures for reusable parts and cleaning equipment).The instructions for use includes the following statements: channel cleaning brush (bw-15b) the channel cleaning brush is used to brush the inside of the instrument and suction channels channel-opening cleaning brush (mh-507) the channel-opening cleaning brush is used to brush the suction cylinder and the instrument channel port 7.4 leakage testing after precleaning, perform leakage testing on the endoscope to ensure that it is waterproof.7.9 cleaning, disinfection, and sterilization procedures for reusable parts and cleaning equipment this section includes the cleaning, disinfection and sterilization procedures for the reusable parts and reprocessing equipment listed below.For all other parts, refer to their respective instruction manuals.For compatible reprocessing methods, refer to section 6.1, ¿compatibility summary¿.Clean, disinfect and sterilize the forceps/irrigation plug according to the instructions given in its instruction manual.Sterilization [caution] the cleaning brushes are not compatible with eto gas sterilization.
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