OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION; CYSTONEPHROFIBERSCOPE
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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 Type
malfunction
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Manufacturer Narrative
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The olympus representative covered and explained the pre-cleaning, process following olympus guideline on reprocessing with the customer.Additionally, the pre-cleaning in-service included all cleaning, disinfection and sterilization information that is contained in the olympus manual.All models reviewed are listed in the product section.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Event Description
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During an in-service reprocessing of fiberscope "cyf-5, it was observed a deviation in the scope cleaning process as the customer mentioned they do not do any pre-cleaning on their urology scopes.Customer also does not conduct an extended soak if the scope sits longer than an hour.Issue was noticed during reprocessing training.There was no harm, infection or user injury reported due to the event.
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Manufacturer Narrative
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The supplemental report is submitted to provide the result of the legal manufacturer¿s investigation.Updates to section e2, e3, g2, h6 e3 title - "sterile processing manager the legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation presumed that the event was caused by a human error.Additionally, it was confirmed that there are no product-related or manufacturing-related events, and there are no safety issues.As stated on the ifu (instruction for use) as a preventive measure, the user manual states: if the endoscope is not immediately precleaned, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.Olympus will continue to monitor field performance of this device.
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