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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the reported failure 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: a stress related component failure.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: 50699224
• Report Number: 9610773-2026-06059
• Device Sequence Number: 12244217
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K931995
• Number of Events Summarized: 1
• Summary Report (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): 09/09/2026

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: N/A-1583
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/09/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown