MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 26 FR.; A22042A

Model Number	A22042A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the resection sheath had damage to the cap.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.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.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
This event occurred during reprocessing.

• Brand Name: RESECTION SHEATH, 26 FR.
• Common Device Name: A22042A
• 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: 21645297
• Report Number: 9610773-2025-02159
• Device Sequence Number: 7624683
• Product Code: HIH
• UDI-Device Identifier: 04042761020985
• UDI-Public: 04042761020985
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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