MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The suspect fiberscope has been returned to olympus for evaluation, and the investigation is ongoing.The physical device evaluation has not been completed.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 tested positive for 1 ufc of bacillaceae.The sampling result date was (b)(6) 2023.The results obtained comply with the target level defined in the dgos / pf2 / dgs / vss1 / 2016/220 instruction of (b)(6) 2016.For an endoscope subjected to high level disinfection and rinsed with sterile water.The microbiological quality of the endoscope is not satisfactory for an endoscope subjected to high-level disinfection and rinsed with sterile water.The olympus will reprocess the fiberscope and perform a new sampling.The olympus received the following answer from the customer: "the germ was identified as an enterobacteria antibiotic resistant".No microbiological report was received.The fiberscope was not reprocessed by the customer and was not disinfected before being send to olympus.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus that the uretero-reno fiberscope distal end sheath had leakage and was used on a patient with bhr (bacteria with high resistance to antibiotics).It is unknown when the reported issue was found.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide the results of the hygiene microbiological investigation microbiological test result, additionally, correction to h10 of the initial report: correction: the first sampling hmi results is being corrected from conform to non conform.The correct information is the first sampling report performed did not conform to speciffication.A second sampling was performed and the results conforms , with results of <1 cfu of revivable microorganism.The sampling result date was (b)(6) 2023.The hygiene microbiological investigation (hmi) first microbiological test results showed a non-conform result to french regulation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Despite good faith attempts the user culture results and cleaning disinfection and sterilization (cds) processes were not shared.The device was evaluated where no abnormalities were found that could have led to the positive culture.The following defects were noted: biopsy channel --- leak; distal end --- burned; bending tube --- deformed without metal exposure; 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, it is likely that reprocessing was conducted insufficiently due to leakage of the device.Growth of microorganisms were reported 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.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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: 17852930
• MDR Text Key: 324807287
• Report Number: 9610595-2023-14416
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2023

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-P6
• 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: 09/05/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/09/2023; 11/30/2023
• Supplement Dates FDA Received: 10/19/2023; 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• 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