MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 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
Event or Problem Description
It was reported, that the subject device exhibited peeling off coating of the insertion tube.The issue occurred, during an unspecified procedure.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
E1: address information: (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: OES URETERO-RENO FIBERSCOPE
• Common Device Name: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20614721
• Report Number: 3002808148-2024-10810
• Device Sequence Number: 21030740
• Product Code: FGB
• UDI-Device Identifier: 04953170340307
• UDI-Public: 04953170340307
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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-P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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