|
Model Number CYF-5 |
Device Problem
Microbial Contamination of Device (2303)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/25/2023 |
Event Type
malfunction
|
Event Description
|
The customer reported to olympus, during reprocessing, the cystonephrofiberscope tested positive for 1 colony forming units (cfus) of micrococcus luteus.The auxiliary channel was sampled.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
|
|
Manufacturer Narrative
|
The suspect device has been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The customer did confirm that there were no deviations or deficiencies concerning reprocessing of the scope.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.The customer did not provide the specific steps taken during the cleaning sterilization and disinfection (cds) process.The hygiene microbiological investigation report indicated the channels of the scope were cultured and less than 1 cfu of any microbes were found.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The device evaluation found the air valve unit was detached, the channel mount and mouth guard piece were damaged, and suction was out of standard.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|
|
|