MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number	CYF-VHA
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned to olympus for evaluation.The customer provided the cleaning, disinfection, and sterilization (cds) process and reported that the endoscope and accessories were culture tested.There was a delay/lag time between the end of clinical use and the start of pre-cleaning.The suction pump was not used to draw water from the forceps channel and the customer is not using the mh-948 to pump air/liquid into the air/water channel.There were no issues with the accessories used for reprocessing.Manual cleaning was performed more than one hour after the case and was not done under immersion.The device passed leak testing.The cleaning solution used was end fresh a and the disinfectant used as aceside.The forceps channel was brushed.The forceps elevator was not moved up and down three times while immersed in the cleaning solution.The olympus endoscope reprocessor-4 (oer-4) was used for reprocessing.The cleaning tube was connected to all channels when the endoscope was sent into the disinfector.The water filter was not replaced within the specified period.The products used to treat the rinse water were normal.The scope was not used after the positive culture was observed and was stored at room temperature with no additional reprocessing.The scope was dried by wiping with the clean paper/towel and was placed in storage without a drying function.The collection was taken after storage and the last date of reprocessing was august 9, 2023.There was no patient infection.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the cysto-nephro videoscope's tip insertion section (up to curved section) and forceps channel tested positive for twice for unexpected contamination of gram positive cocci and staphylococci (staphylococcus spp.).The scope was retested 4 days later and was negative.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 persons to which the scope could have been a contributory cause.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information provided by the customer: the customer provided additional cleaning, disinfection and sterilization information.There were no deficiencies in the reprocessing of the device, there was no delay/lag time between the end of clinical use and the start of pre-cleaning, and there were no problems with the endoscope washer.End quick cleaning solution was used.The disinfectant was within its expiry date and the concentration was effective and the quality of the rinse water was controlled.The device was quarantined after positive culture observed and stored at room temperature (with the same level as the oxygen concentration in the air).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based the legal manufacturer's final investigation.The reported event was not confirmed as the device was not microbiologically tested by olympus.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.However, it is likely that reprocessing was insufficient due to deviation from the instruction manual.Cyf-vha has a cleaning manual, and the reprocessing method is described in the cleaning manual.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Common Device Name: CYSTO-NEPHRO VIDEOSCOPE
• 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: 17719496
• Report Number: 3002808148-2023-09651
• Device Sequence Number: 17964190
• Product Code: FAJ
• UDI-Device Identifier: 04953170310508
• UDI-Public: 04953170310508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Health Professional
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 09/15/2023; 09/21/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 09/17/2023; 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown