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

Model Number URF-V2

Device Problem Microbial Contamination of Device (2303)

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

Event Date 01/16/2024

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, disinfection, and sterilization process stating that precleaning was performed immediately after the procedure.The customer did confirm that there were no deviations or deficiencies concerning reprocessing of the scope. air/water was aspirated through the instrument/suction channel with a suction pump.During manual cleaning, the device passed the leak test.The detergent used was enzymex.The disinfectant used was enzymex, and the channels were flushed.All channels were connected with tubes when the endoscope was set up in the automated endoscope reprocessor (aer).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 blowing filtered compressed air and stored in simple cabinet.Olympus is the maintenance company.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

It was reported that the uretero-reno videoscope 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

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, results of third-party testing, the device evaluation and the lms final investigation.The lm reviewed the customer provided the cds processes where information to judge deviation from the instructions for use (ifu) was not identified.The user facility provided the following result of the culture test, performed at the third-party labs: sampling date: jan 16, 2024.Sampling from: all channel (biopsy channel).Cfu: unknown.Bacterial identification: unknown.Detection of bacteria higher than the local standard value from rinse water of biopsy channel.Olympus provided the following result of the culture test, performed at the third-party labs: sampling result date: (b)(6) 2024.Sampling from: all channel (biopsy channel).Cfu: <1cfu/endoscope.Bacterial identification: no detection.The device was evaluated where no abnormalities were found that could have led to the positive culture.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." 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: 18656073
• MDR Text Key: 334736264
• Report Number: 9610595-2024-02608
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172246
• 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: 04/01/2024

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-V2
• 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: 01/23/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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