MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 26 FR.

Model Number	A22042A
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported "tip missing from top of 26 fr cystoscope noted at end of case (prostate resection therapeutic procedure) when completing the set count and they have not obvious on first set count pre op".There were no reports of patient harm.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is to inform updates in section d9 and g1.D9 updated from yes to no.G1 updated the contact office email address to olympusmdrcontact@olympus.Com.

• Brand Name: RESECTION SHEATH, 26 FR.
• Common Device Name: RESECTION SHEATH
• 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: 22672951
• Report Number: 9610773-2025-04832
• Device Sequence Number: 7533329
• Product Code: HIH
• UDI-Device Identifier: 04042761020985
• UDI-Public: 04042761020985
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K931994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: A22042A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 07/31/2025
• 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