MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Inner sheath, for 26 Fr. outer sheath; Endoscope sheath, reusable

Model Number	A22040A
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Urethral Stenosis/Stricture (4501); Urinary Incontinence (4572)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury

• Brand Name: Inner sheath, for 26 Fr. outer sheath
• 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 ; +1(508)207-7661
• MDR Report Key: 50574050
• Report Number: 9610773-2026-05942
• Device Sequence Number: 13311197
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K931995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: A22040A
• Device Lot Number: 26215
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: A22026A Outer sheath; WA22366A Working element
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Male