MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number	URF-V
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during reprocessing, the uretero-reno videoscope tested positive for 2 colony forming units (cfus) of aeromonas hydrophila.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.
Additional Manufacturer Narrative
The device evaluation is ongoing.Prior to the device evaluation, the device was sent out for additional microbiological testing.The microbiological analysis results are pending.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Additional Manufacturer Narrative
New information added to the following fields: d8, d9.This report is being supplemented to provide additional information based on the results of third-party testing, the device evaluation and the lms final investigation.Despite good faith attempts the user cleaning disinfection and sterilization (cds) processes were not shared.Olympus/ the user facility provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2024.Sampling from: all channels.Cfu: <1cfu.Bacterial identification: n/a.The device was evaluated where the following abnormalities were found that could have led to the reported event; the device was repaired by a third party including the bending section cover adhesive, the insertion tube, the insertion tube protector, the scope connector and the switch button.As the device was repaired by a third party with non-olympus materials; the defined biocompatible characteristics are no longer guaranteed, for example; it was unknown if an improper adhesives was used or improper materials were used.Additionally, the defined mechanical characteristics are no longer guaranteed; for example the melting of improper insulation material instead of the ceramic manufactured 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.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the ifu before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." as a result of confirming the contents of the instruction manual, reprocess method is described on the items below; chapter 6 compatible reprocessing methods and chemical agents chapter 7 cleaning, disinfection, and sterilization procedures olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Common Device Name: URETERO-RENO 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: 19115092
• Report Number: 3002808148-2024-03525
• Device Sequence Number: 15229603
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2017
• 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