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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
The subject device referenced in this report was not returned for evaluation, therefore the device evaluation could not be completed at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported by the customer, after a routine microbiological test, the user detected an unexpected contamination of the oes cystonephrofiberscope.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.
 
Event Description
Additional information was received from the reporter.All channels were sampled.The oes cystonephrofiberscope tested positive for one (1) colony forming unit of burkholderia cepacia.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the reporter, the hygiene microbiological investigation report, and the device evaluation.After the device was returned to olympus, it was sent out for additional testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured.The device tested positive for less than one (1) colony forming unit of microorganisms.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The device was returned to olympus for evaluation.The reported issue was not confirmed per the hygiene microbiological investigation.During inspection, there were no findings.
 
Manufacturer Narrative
This report is being supplemented to provide additional information, based on the device evaluation.And the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been 7 years, since the subject device was manufactured.Based on the results of the investigation, it is unlikely, the positive culture was caused by the device.Growth of microorganisms were found through culture testing by the user, after reprocessing.However, when olympus culture tested, after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed, to french recommendation.The following is included in the instructions for use (ifu): "after using the instrument, reprocess and store it according to the instructions in chapters 5 through chapter 9.Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance".
 
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Brand Name
OES CYSTONEPHROFIBERSCOPE
Type of Device
CYSTONEPHROFIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key12597603
MDR Text Key277159564
Report Number8010047-2021-12912
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170339417
UDI-Public04953170339417
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCYF-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/16/2021
Initial Date FDA Received10/08/2021
Supplement Dates Manufacturer Received10/20/2021
12/23/2021
Supplement Dates FDA Received11/09/2021
01/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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