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

Model Number	URF-P7R
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the uretero-reno fiberscope had black spots in the scope due to broken fiber.The issue was found during inspection.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: eyepiece has foreign material.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found image guide bundle has significant breakages and an abnormal sound is made due to deformation of second bending section.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and customer-provided information.When the foreign material was identified, olympus requested additional information from the customer on their reprocessing practices.The customer reported the device was cleaned, disinfected, and sterilized before it was sent in for repair.According to the customer, there was no delay in the start of the pre-cleaning.The customer reported that during manual cleaning, there were no abnormalities in the reprocessing accessories and the manual cleaning was done within 1 hour of the procedure.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.The device instructions for use document was reviewed.Review showed relevant instruction related to detection of the issue in chapter 3: preparation and inspection.Also, the reprocessing manual provides relevant prevention steps in chapter 5: reprocessing the endoscope.The source of the foreign material could not be specified and there was no physical damage to the device where the foreign material was found.The investigation could not confirm that the customer's reprocessing was conducted in accordance with the device instructions; it was determined possible the issue occurred due to insufficient cleaning.However, a definitive root cause of the foreign material could not be identified.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: 18301151
• Report Number: 9610595-2023-19187
• Device Sequence Number: 16950117
• Product Code: FGB
• UDI-Device Identifier: 04953170435102
• UDI-Public: 04953170435102
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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