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 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

The olympus scope was sent to an independent laboratory for culture testing and results are still pending.The investigation is ongoing and follow up with the customer is currently being performed.After culture testing, the device will be evaluated.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported that, during reprocessing, the videoscope tested positive for one colony forming units (cfus) of stenotrophomonas maltophilia.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

Correction to b5 of the initial report, please see b5 for further clarification.Correction to h6 "health effect - impact code" from "2645 - no patient involvement" to "2199 - no health consequences or impact.It was observed during the device inspection, that the videoscope exhibited an additional reportable event as there was brown residue remaining inside the mouthpiece of the endoscope.It was not possible to identify when the foreign material has been attached to the subject device.There is a possibility that the subject device was used on a patient with the foreign material attached.There were no reports of patient harm as a result of this event.The device evaluation is ongoing.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 one colony forming unit of revivable micro-organisms at 30 degrees celsius.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.Once the investigation has been completed, a supplemental report will be submitted with the complete device evaluation results.

Event Description

Correction to the initial report, it was reported that, during reprocessing, the videoscope tested positive for >80 colony forming units/endoscope (cfus) of brevundimonas species on (b)(6) 2024 and 1 cfu/endoscope of stenotrophomonas maltophilia on (b)(6) 2024.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 legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes and the lms final investigation.The lm reviewed the customer provided the cds processes where no obvious deviations from instructions for use (ifu) were identified.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 for the bacteria contamination 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.Based on the results of the investigation, a root cause for the brown foreign material was likely due to the physical damage of the device where the brown foreign material was detected.Labeling ifu warns on improper reprocessing as follows: "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: 19064115
• MDR Text Key: 340459697
• Report Number: 9610595-2024-07306
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/10/2024; Not provided
• Supplement Dates FDA Received: 04/18/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2018
• 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