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

Model Number	URF-P7
Medical Device Problem Codes	Mechanical Problem (1384); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the fiberscope had a tip angle lock.It is unknown when the issue occurred.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.E1: establishment name: (b)(6).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information and the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.An additional reportable malfunction was found; external diameter of the bending section cover increased.Based on the results of the investigation, the angulation lock at the distal end section was likely caused by air that leaked out of the channel was found, water invading from the portion corroded on the angulation mechanism, causing the failure in angulation control knob operation and the external diameter of the bending section cover increased was likely caused by stress of repeated use, external factors, or handling; however a definitive root cause could not be identified for either event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The event can be detected/prevented by following the instructions for use (ifu) which state: suggested event 1: angulation lock at the distal end section occurred.The instruction manual operation manual¿ urf-p7, chapter 3 preparation and inspection, 3.3 inspection of the endoscope¿ describes the methods for inspection on the suggested event.Suggested event 2: external diameter of a-rubber increased.The instruction manual operation manual¿ urf-p7, chapter 3 preparation and inspection, 3.3 inspection of the endoscope¿ describes the methods for inspection on the suggested event.Olympus will continue to monitor field performance for 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: 20056369
• Report Number: 9610595-2024-16868
• Device Sequence Number: 8826699
• Product Code: FGB
• UDI-Device Identifier: 04953170435096
• UDI-Public: 04953170435096
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2022
• 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