MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING INSERT, 8.5 MM, 8 FR. CHANNEL, FOR A42021A; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number	A42091A
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
He device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device evaluation, the working insert, exhibited scratches on yellow seal and damaged adhesive between components.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the following led to the malfunction: glue failure: due to the temperature influences on the product during the recycling process, different linear expansions occur between the adhesive and the steel.According to current knowledge, inadequate adhesive preparation and linear expansion can lead to adhesion and cohesion fractures.As a result, the adhesive detaches from the steel surface.In the fmi area, the corrugated tube is straightened during final assembly.During straightening, stresses can occur in the adhesive.With further stress (straightening) within the value stream process, the adhesive can completely detach from the steel surface and then fall off.Another factor that increases the risk of defects is the lack of a clearly defined production process.Cracks in the rubber seal: the cause of this issue is wear and tear and/or improper handling of the affected device.The cracks in the seals are signs of wear and tear and can be attributed to frequent use and a lack of maintenance, in line with the age of the item.A crack in the sealing ring is highly likely to result in a leak in the inner shaft.Olympus will continue to monitor field performance for this device.

• Brand Name: WORKING INSERT, 8.5 MM, 8 FR. CHANNEL, FOR A42021A
• Common Device Name: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• 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: 18962051
• Report Number: 9610773-2024-00828
• Device Sequence Number: 7050797
• Product Code: GCP
• UDI-Device Identifier: 04042761023689
• UDI-Public: 04042761023689
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: A42091A
• Device Lot Number: 191W-0141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• 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: 09/23/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown