MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Resection sheath, 8 mm, for 8.5 mm/26 Fr. outer sheath, ABS; Endoscope sheath, reusable

Model Number	A42011A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned to the service center.During inspection of the device, the resection sheath ceramic tip had cracks.There was no harm or injury reported.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the no image malfunction: cause traced to a stress problem; expected or random component failure without any design or manufacturing issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: Resection sheath, 8 mm, for 8.5 mm/26 Fr. outer sheath, ABS
• 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: 50766348
• Report Number: 9610773-2026-06170
• Device Sequence Number: 9224855
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: A42011A
• Device Lot Number: 20X02(INJXG)
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/23/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2020
• 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