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 10/11/2023

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

The customer reported to olympus, during reprocessing, the uretero-reno videoscope tested positive for less than 2 colony forming units (cfus) with a detection of bacillus and mesophile.All channels were sampled.The user did not report any contamination or any other serious deterioration in the state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

Corrected fields: b3, e2/e3 (inadvertently missed).This report is being supplemented to provide additional information based on the results from third-party testing, the customer provided cleaning disinfection and sanitization (cds) practices, the device evaluation, and the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2023.Sampling from: all channels.Colony forming unit (cfu): <1 cfu.Bacterial identification: none detected.The customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The customer confirmed that there were no deviations or deficiencies concerning reprocessing of the scope.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.The device was rinsed before manual disinfection and all channel flushed with and immersed into "anios clean excel d".Filtered water was used to rinse after disinfection.The automated endoscope reprocessor (aer) used was a soluscope serie 4, which was confirmed to have no defects.The detergent and the disinfectant used was "soluscope cln" and "soluscope paa".All channels were connected with tubes when the endoscope was setting up into the aer.The concentration and expiration date of the disinfectant was controlled.The water quality of the rinse water was controlled via water filter, which was replaced periodically according to the instructions for use (ifu).The device was dried by filtered compressed air and wiped with a clean towel.The scope was stored in a simple cabinet.The returned device was evaluated and the following defect was noted during the evaluation: a leak from the bending section cover.This defect alone is not considered severe enough to cause a potential adverse event.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 instructions for use (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: 18193447
• MDR Text Key: 329000995
• Report Number: 9610595-2023-17948
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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-V3
• 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: 11/01/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/25/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• 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