MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, LONG, FOR WA22018A AND WA22019A; ENDOSCOPE SHEATH, REUSABLE

Model Number	WA22017A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the rigid endoscope sheath, which is an olympus asset with no reported complaint.During the evaluation of the device, it was observed that the ceramic tip is broken.The investigation center assessed the condition and determined that the damage was most likely due to stress.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.Olympus detected this issue with a returned olympus asset during device inspection and there was no reported customer product complaint or allegation, therefore there is no information of the customer reported date of event.Additional information will be provided once available.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: ceramic tip is broken du to stress.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: INNER SHEATH, LONG, FOR WA22018A AND WA22019A
• 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 ; 5082077661
• MDR Report Key: 25425419
• Report Number: 9610773-2026-04335
• Device Sequence Number: 15935007
• Product Code: HIH
• UDI-Device Identifier: 04042761051514
• UDI-Public: 04042761051514
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 06/08/2026

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: WA22017A
• Device Lot Number: 199W-0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2019
• 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