MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A; RIGID ENDOSCOPE SHEATH

Model Number	A22040T
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 device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
During the device evaluation, the inner sheath exhibited the ceramic tip broken off.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d8, h3, h6 and h11.The device was returned to olympus for inspection, and the customer's complaint was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.A definitive root cause was not identified, however based on the results of the investigation, it is likely that the damage was thermally and mechanically induced.Olympus will continue to monitor field performance for this device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A
• Common Device Name: RIGID ENDOSCOPE 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20242195
• Report Number: 9610773-2024-02250
• Device Sequence Number: 8042797
• Product Code: HIH
• UDI-Device Identifier: 04042761029360
• UDI-Public: 04042761029360
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 09/30/2024

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: A22040T
• Device Lot Number: ACC-22403-HM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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