It was reported, the gastrointestinal videoscope was reprocessed without an auxiliary water channel connector, did not disinfect the lines, and did not know how to microtest the reprocessor.The issue occurred during reprocessing.There were no reports of patient harm.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, an olympus field service engineer confirmed the reported information.However, several attempts were made to obtain additional information, but no response was received from the customer.Therefore, the root cause of the reported information is unable to be determined.As the serial number was not provided the device¿s instructions for use (ifu) cannot be reviewed.Please see below for oer-aw ifu statement which states: ifu: oer-aw in the related complaint instructs on the event as follows: chapter 4 basic endoscope reprocessing operations 4.8 connecting tube installation ¿ attach all of the connecting tubes specified according to the type of the endoscope.If reprocessing is performed without attaching all of the required connecting tubes, reprocessing may be ineffective.Although the ¿list of compatible endoscopes/connecting tubes ¿ shows the applicable connecting tubes for each endoscope, it may not list the latest endoscope models.If your endoscope model is not listed, contact olympus for more information.Olympus will continue to monitor field performance for this device.
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