MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Ureteroscope 6.7/8.4 Fr. x 430 mm, 5°, angled ocular, 4.2 Fr. channel; Rigid ureteroscope

Model Number	WA2UR11A
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tip was coming out during an inspection for use involving an olympus rigid ureteroscope.There was no patient involvement reported.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.The date of the event is unknown.Additional information will be provided once available.

• Brand Name: Ureteroscope 6.7/8.4 Fr. x 430 mm, 5°, angled ocular, 4.2 Fr. channel
• Common Device Name: Rigid ureteroscope
• Manufacturer (Section D): Olympus Winter & Ibe GmbH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): Olympus Winter & Ibe GmbH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50917873
• Report Number: 9610773-2026-06407
• Device Sequence Number: 5776554
• Product Code: FGB
• UDI-Device Identifier: 04042761086387
• UDI-Public: 04042761086387
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: WA2UR11A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown