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 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the utero-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

Correction d9: checked box returned to manufacturer and added date returned to manufacturer apr 3, 2024.Correction h6 component code: 841-imager.Updated d section information: olympus received additional information after the initial report that the device was a different model number; therefore, the model and udi have been updated.This report is being supplemented to provide additional information based on the legal manufacture's (lm) final investigation.The subject device was returned for device investigation.The device evaluation could not conclusively specify the root cause of the event.Based on the following investigation results, there is a possibility of contamination from the environment, as the customer reported that there were problems with the sampling method and sampling environment implemented at the facility.The issue was not confirmed, as the scope was not microbiologically tested by olympus.There was no report of the subject device being used in procedure after the suggested event was reviewed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.No information to judge deviation from instructions for use (ifu) was confirmed from review of reprocessing steps provided from the user.Ifu states as follows: ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿ to warn about inappropriate reprocessing.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that the colonovideoscope tested positive for <15 colony forming units (cfus) of staphylococcus hominis.The device was reprocessed and sampled again and results showed no growth aerobically after two days incubation.

• 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: 19047746
• MDR Text Key: 339576496
• Report Number: 9610595-2024-07090
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2024
• 2 Devices were Involved in the Event: 1 2

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• 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