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

Model Number	URF-P7
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2024
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 observed during the device inspection, that the uretero-reno fiberscope exhibited bending section cover was missing.There were no reports of patient involvement.
Additional Manufacturer Narrative
Updated: h3, h6, h11.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 of the reported bending section missing/perforated rubber cover could be determined, however, the damage was likely caused by hitting the curved rubber with a sharp object/use of excessive force and resulting in leakage at the distal end.The event may be detected/prevented by following the instructions for use which state: urf-p7 reprocessing manual chapter 1.4 precautions ¿ warning perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause damage to the bending mechanism or other malfunctions.Use of a leaking endoscope may also pose an infection control risk.Instructions urf-p7 operation manual chapter 4.2 insertion of the endoscope (for choledocho use) insert and/or withdraw the endoscope into/from a trocar tube slowly and deliberately.Forcefully inserting and/or withdrawing the endoscope may damage the bending section.Instructions urf-p7 reprocessing manual chapter 3.1 insertion - caution the instructions provided in this manual regarding compatible reprocessing methods are not valid for olympus devices repaired by a non-olympus facility.Olympus repairs devices to manufacturer¿s specifications using original equipment manufacturer¿s (oem) materials.The use of non-oem materials to repair an olympus device may affect the material compatibility and reprocessing efficacy of the device with certain reprocessing chemicals or methods.In the event that your device has been repaired by a non-olympus facility, contact the repair facility for instructions regarding compatible reprocessing methods.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: 20504206
• Report Number: 9610595-2024-21542
• Device Sequence Number: 18242912
• Product Code: FGB
• UDI-Device Identifier: 04953170435096
• UDI-Public: 04953170435096
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: Other
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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