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

Model Number CYF-VH

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/11/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, during reprocessing, the cysto-nephro videoscope tested positive for 1 cfu of micrococcus luteus on october 24, 2023.The device was retested on november 9.2023.The second test result was positive for 1 cfu of kocuria palustris.All channels were 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 hygiene microbiological investigation report indicated the channels of the scope were cultured and found less than 1 cfu of any microbes.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 bending section glue was separated.Attempts to retrieve additional information from the customer are in progress.Once the investigation has been completed, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information including the legal manufacturer's final investigation and further information provided by the customer.According to the customer, there was no suspicion of patient infection.Precleaning was performed immediately after the procedure.Water was aspirated through the instrument/suction channel with a suction pump.It was unknown if the forceps elevator was raised and lowered three times in water during aspiration.It was unknown if aspiration was done with both 1st and 2nd position of the suction valve.It was unknown if the air/water balloon channels were flushed with water and air by using maj-1444 air/water valve and maj-629 air/water cleaning adaptor.It was unknown if the air/water channel was flushed with water and air using the mh-948 cleaning adaptor.The device passed the leak test.The detergent used was alkazyme alkapharm.The instrument/suction channel was brushed.The forceps elevator was raised and lowered three times when submerged in detergent solution.The forceps elevator was not flushed.The distal end was brushed with the channel opening brush and single use soft brush (maj-1888).It was unknown if the distal end was flushed with the maj-2319 distal end flushing adaptor.The device was rinsed before manual disinfection.The disinfectant used was anios oxygyn hl.All of the channels were flushed with and immersed in the disinfectant.Sterile water was used to rinse.The concentration and expiration date of the disinfectant is controlled.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over a year since the subject device was manufactured.Based on the results of the investigation and the information provided, the cause of the bacteria initially detected could not be determined.No abnormalities were found in the parts related to where the bacteria were initially detected were identified during the device evaluation.From the reprocessing information provided by the customer, there were no obvious deviations from the instruction manual.Therefore, the relationship between the device and the initially detected bacteria could not be identified.The event can be detected/prevented by following the instructions for use: the cysto-nephro videoscope cyf-vh/cyf-vhr reprocessing manual provides detailed instructions and guidance.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: 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: 18288418
• MDR Text Key: 330824389
• Report Number: 3002808148-2023-13927
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2022
• 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