The subject device was not returned to any of olympus locations.Therefore, olympus could not investigate the subject device.Omsc could not review the manufacturing history record (dhr) because the serial number was unknown.The exact cause of the reported event could not be conclusively determined.However, based upon the information from olympus (b)(4), there was the possibility that this phenomenon was attributed to the human error.Olympus stated the appropriate reprocessing of cyf-5 and the counter measures against abnormalities in the instruction manual of cyf-5.
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Olympus medical systems corp.(omsc) was informed from the user that during reprocessing, it was found that the following.¿the department provides decontamination and sterilization service to both internal and external customers.The department is accredited to iso 13485:2016.On occasions we process flexible cystoscopes for an external customer north bristol nhs trust.On the (b)(6) is was brought to our attention by our external authorized engineer for decontamination that the department had been processing this particular model of flexible cystoscope on the flex cycle instead of the duo cycle which is advised by the manufacturer in their instructions for use.¿ the facility staff had reviewed, amended/updated and shared the procedure.Also they had reminded of the importance of checking the manufacturers ifu's before processing medical devices.There was no report of patient injury associated with the event.
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