MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CYSTOSCOPE, 30°, 17 FR. X 225 MM, 9 FR. CHANNEL, OCULAR ANGLE 45°; RIGID CYSTOSCOPE

Model Number	A20919A
Medical Device Problem Codes	Break (1069); Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the rigid cystoscope exhibited chipped and broken inner barrel assembly, and extremely worn distal terminal.There was no patient involvement.
Additional Manufacturer Narrative
The date of event is unknown.A supplement report will be submitted if provided.The device was not returned to olympus for inspection.However, the device was inspected by field service.A root cause could not be identified.Based on the results of the investigation, it is likely the most probable cause of the malfunction was traced to component failure.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTOSCOPE, 30°, 17 FR. X 225 MM, 9 FR. CHANNEL, OCULAR ANGLE 45°
• Common Device Name: RIGID CYSTOSCOPE
• 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 ; 5082077661
• MDR Report Key: 24686307
• Report Number: 9610773-2026-02214
• Device Sequence Number: 9770486
• Product Code: GCP
• UDI-Device Identifier: 04042761030052
• UDI-Public: 04042761030052
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: Other
• Device Model Number: A20919A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown