MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE

Model Number	URF-P5
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it was likely that the peeling of coating on the insertion tube was caused by the same cause as other defects.However, we were not able to determine whether the peeling was due to stress, handling, or other factors.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
Customer sent repair request for device lg (light guide) suspicion of breakage.There is no patient involvement associated on this event.Device evaluation found coating peeling at the insertion part (major axis 4mm or more ).This report is being submitted for coating peeling at the insertion part of the device.
Additional Manufacturer Narrative
The subject device was received and evaluated at service repair olympus japan.Device inspection found coating peeling at the insertion part (major axis 4 mm and more).Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 26-jan-2022.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: OES URETERO-RENO FIBERSCOPE
• Common Device Name: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13589062
• Report Number: 8010047-2022-03482
• Device Sequence Number: 5819391
• Product Code: FGB
• UDI-Device Identifier: 04953170340307
• UDI-Public: 04953170340307
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2022

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-P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2022
• Supplement Date Received by Manufacturer: 03/08/2022; 11/08/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/05/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2017
• 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