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 Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

The suspect device 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 microbiological analysis results are pending.Attempts to retrieve additional information from the customer are in progress.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus, during reprocessing, the uretero-reno fiberscope tested positive on (b)(6) 2023, for 2 cfus of unspecified microbes.The device was tested (for the second time) positive on (b)(6) 2023, for 12 cfus of unspecified microbes.The device tested positive (third time) on (b)(6) 2023, for 23 cfus of unspecified microbes, and the device tested positive (fourth time) on (b)(6) 2023, for 3 cfus of unspecified microbes.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

This report is being supplemented to provide additional information based on results of third-party testing, the device evaluation, and the legal manufacturer's final investigation.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2023; sampling from: all channels; cfu:2cfu; bacterial identification: bacillaceae.Sampling date: (b)(6) 2023; sampling from: all channels; cfu:12cfu; bacterial identification: bacillaceae.After sbc replaced the forceps channel, forceps stopper, and ns-u of the device and reprocessed it again, the microbiological test was negative.(see action item # ga23458725-6).Sampling date: (b)(6) 2024; sampling from: all channels; cfu:<1cfu; bacterial identification: n/a.The customer did not provided the facility cleaning disinfection and sanitization (cds) practices/cds checklist.The device was evaluated and damage and or scratches were observed on the forceps channel, forceps stopper/ks mouthpiece and insertion tube/ns-u.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 definitive root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing and confirmed when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair.After repair of the device and replacement of the observed damaged forceps channel, forceps stopper/ks mouthpiece and insertion tube, the device was again culture testing by olympus after reprocessing in accordance with the ifu and the results conformed to the regulation's recommendation.The root cause of the issue was likely the result of insufficient reprocessing due to damage on the device.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 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: 18036524
• MDR Text Key: 326916218
• Report Number: 9610595-2023-16142
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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-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: 10/09/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• 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