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

Model Number	URF-P7R
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the uretero-reno fiberscope had crystals on the end of the scope.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, the reported malfunction was reproduced.The likely cause could be leakage from the bending section cover, plastic distal end cover, and biopsy channel.The reprocessing was not conducted properly, as a result of which the foreign body was not eliminated.However, a definitive root cause could not be determined.The event can be detected and prevented in accordance with the following instructions for use (ifu).Detection methods are written in ifu: uretero-reno fiberscope, urf-p7, urf-p7r, operation manual, chapter 3 preparation and inspection.Prevention measures are written in ifu: uretero-reno fiberscope, urf-p7, urf-p7r, reprocessing manual chapter 5 reprocessing the endoscope.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Common Device Name: 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: 20251667
• Report Number: 9610595-2024-18695
• Device Sequence Number: 20873772
• Product Code: FGB
• UDI-Device Identifier: 04953170435102
• UDI-Public: 04953170435102
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: URF-P7R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown