MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the cystonephrofiberscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope.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 not been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The microbiological analysis results are pending.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.Pre-soaking was performed.The forceps elevator was raised and lowered three times when submerged in the detergent solution and flushed.The detergent used was anios.The instrument/suction channel, balloon channel, suction cylinder, instruction channel port, and forceps elevator were brushed.The device was rinsed before manual disinfection.The disinfectant used was anios, and the channels were flushed with filtered water.The concentration and expiration date of disinfectants were controlled.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 manufacture's (lm) review of the customer completed cleaning disinfection and sterilization (cds) checklist and the lms final investigation.Despite good faith attempts the user culture results were not shared.The lm reviewed the customer provided the cds processes where no obvious deviations from instructions for use (ifu) were identified.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, because the user device was not returned for evaluation and the user culture results not shared, the reported event could not be confirmed and a root cause could not be determined.There is a reprocessing manual for cyf-5, and it described the reprocessing procedures.Olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18665227
• MDR Text Key: 336063150
• Report Number: 3002808148-2024-01205
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2023
• 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