Model Number CYF-5 |
Device Problem
Device Reprocessing Problem (1091)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was not returned to any of olympus locations.Therefore, olympus could not investigate the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Event Description
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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 10th march 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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Manufacturer Narrative
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This supplemental report is being submitted to provide the subject device evaluation result.The subject device was not returned to any of olympus locations.The exact cause of the reported phenomenon could not be conclusively determined.Olympus medical systems corp.(omsc) surmised that the reported phenomenon was attributed to the human error.
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Search Alerts/Recalls
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