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 03/06/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the uretero-reno videoscope tested positive for staphylococcus aureus.The issue was found during a routine culture of the scope.Sampling occurred at reprocessing, before use.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

The olympus scope was sent to an independent laboratory for culture testing and the results are currently pending.The device was returned to olympus and the device evaluation is currently in process.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device evaluation, microbial sampling and final investigation from the legal manufacturer.The device was evaluated and it passed incoming inspection, there was no need for repair.Prior to the device being evaluated, the scope was sent to an independent laboratory for culture testing.All channels were sampled.The device tested positive for less than one (1) colony forming unit of unspecified micro-organisms.The obtained results are in conformance with the requirements.The investigation was unable to determine the cause of the positive culture.Information regarding the cleaning, disinfection and sterilization (cds) practices performed at the user facility was unable to be obtained.The instructions for use (ifu) addresses this failure: ifu warns against improper reprocessing with the direction that ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." if additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information regarding this event, refer to b5.

Event Description

The customer did not use the scope between the different sampling dates, the scope had been quarantined when the results were first positive.

• 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: 17007757
• MDR Text Key: 316012926
• Report Number: 9610595-2023-08074
• Device Sequence Number: 1
• Product Code: FGB
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2023

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/25/2023; 06/27/2023
• Supplement Dates FDA Received: 06/23/2023; 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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