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

Model Number URF-V3

Device Problem Microbial Contamination of Device (2303)

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

Event Date 01/17/2024

Event Type  malfunction  

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.The device was rinsed before manual disinfection.The disinfectant used was amios clean exel d, and the channels were flushed with tap water.The concentration and expiration date of the disinfectant were controlled.The automated endoscope reprocessor (aer) used was soluscope 4 with soluscope cln detergent and soluscope paa disinfectant.The water quality was controlled with a water filter, and the filter was replaced periodically in accordance with the instructions for use.The device was dried by wiping with a clean towel, blew filtered compressed air, and stored in a simple cabinet.  once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

It was reported that, during reprocessing, the uretero-reno videoscope tested positive for 2 colony forming units (cfus) of coagulase-negative staphylococci and micrococcus luteus.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

This report is being supplemented to provide additional information based on the results of third party testing, device evaluation, and the legal manufacturer's (lm) final investigation.The lm reviewed the customer provided cleaning sterilization and disinfection (cds) processes where information to judge deviation from the instructions for use (ifu) was not identified.Olympus provided the following results of the culture test prior to repair, performed at the third-party labs: sampling date: (b)(6) 2024.Sampling from: all channels.Colony forming unit (cfu): 1cfu.Bacterial identification: micrococcaceae.Sampling date: (b)(6) 2024.Sampling from: all channels.Cfu: 1cfu.Bacterial identification: bacillaceae.Olympus provided the following results of the culture test performed at the third-party labs, following device repair in which the biopsy channel was replaced: sampling date: (b)(6) 2024.Sampling from: all channels.Cfu: <1cfu.Bacterial identification: n/a.The device was evaluated and found channel mount, biopsy channel, and the insertion section mount were scratched.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 and confirmed in olympus third party testing.However, when olympus culture tested after reprocessing in accordance with the ifu after 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." olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18672847
• MDR Text Key: 334981345
• Report Number: 9610595-2024-02784
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• 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