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

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".

• 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 Key: 12597603
• MDR Text Key: 277159564
• Report Number: 8010047-2021-12912
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• 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 Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 10/20/2021; 12/23/2021
• Supplement Dates FDA Received: 11/09/2021; 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1