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 08/30/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, during reprocessing, the uretero-reno videoscope tested positive for 11 colony forming units (cfus) of microorganisms revivable at 30 degrees celsius.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

The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.The customer provided the cds process stating that precleaning was performed immediately after the procedure.Water was aspirated through the instrument/suction channel with a suction pump.During manual cleaning, the forceps elevator was not moved to raise and lower 3 times in water during aspiration and was not flushed.Aspiration was done with the first and second position of the suction valve.The air/water and balloon channels were not flushed with water and air.The device passed the leak test.The detergent used was anios.The instrument channel port was brushed.The distal end was not flushed or brushed.The device was rinsed before manual disinfection.The disinfectant used was anioxyde.The channels were flushed and immersed into the disinfectant.The channels were flushed with sterile water.The automated endoscope reprocessor (aer) used was wd440 with wassenburg detergent and wassenburg disinfectant.All channels were connected with tubes when the endoscope was set into the aer.The concentration and expiration date of the disinfectant was controlled.The water quality was filtered, and the filter was replaced periodically in accordance with the instructions for use.The device was dried by wiping with sterile paper and blew with filtered compressed air and stored in a typhoon.Olympus is the maintenance company.After the device was returned to olympus, it was sent out for additional testing.The microbiological analysis report indicated the channels of the scope were cultured and the results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The reprocessing steps provided by the user were reviewed where the following deviation from instructions for use (ifu) was confirmed: brushing was not performed for biopsy channel at manual cleaning.The device was evaluated where no abnormalities were found that could have led to the positive culture.The following defects were noted: bending rubber glue separated, biopsy channel scratched.However, these defects alone are not considered severe enough to cause a potential adverse event.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 deviation from instructions for use (ifu) was confirmed therefore, reprocessing may have been conducted insufficiently.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with ifu before repair, the results conformed to the regulation's recommendation.The user may be able to prevent the suggested event by handling the device in accordance with the following item in ifu: reprocessing manual_ reprocessing the endoscope_ manually cleaning the endoscope_ brush the channel.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: 17860989
• MDR Text Key: 324801255
• Report Number: 9610595-2023-14490
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170435119
• UDI-Public: 04953170435119
• 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
• Report Date: 10/30/2023

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: 09/06/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• 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