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  

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

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 july 4, 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.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17852920
• MDR Text Key: 324789721
• Report Number: 9610595-2023-14415
• 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
• Report Date: 10/02/2023

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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