MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A; ENDOSCOPE SHEATH, REUSABLE

Model Number	A22040T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported event was confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: overload or deterioration over time.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported during a therapeutic transurethral resection of the prostate procedure, the beak at the tip of inner sheath was damaged.The procedure was completed by changing to another device, and there were no reports of patient harm.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to e1-title and e3-occupation.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A
• Common Device Name: ENDOSCOPE SHEATH, REUSABLE
• 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: 25055566
• Report Number: 9610773-2026-03441
• Device Sequence Number: 21189093
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• Combination Product (Y/N): N
• PMA/510(K) Number: K931995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: A22040T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown