MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING INSERT, 8.5 MM, 8 FR. CHANNEL, FOR A42021A; HYSTERO-RESECTOSCOPE WORKING INSERT

Model Number	A42091A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus as part of the asset return process.In addition to the reportable findings documented in b5, the device evaluation also found deep dents on the trocar sheath.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The olympus hystero-resectoscope working insert was returned as part of the asset return process.Upon inspection and testing of the returned device, it was found that the glue between the channels was blistering/peeling.There was no procedural or patient involvement associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Additional information added to fields h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction mentioned on b5 was found during the device evaluation.Based on the results of the investigation, it is likely the following led to the malfunction: - issue #1 glue between channels broken, and issue #3 peeling glue: due to the temperature effects on the product during the recycling process, different linear expansions occur between the adhesive and the steel.According to current knowledge, the lack of adhesive preparation and the linear expansion can lead to adhesion and cohesion fractures.As a result, the adhesive detaches from the steel surface.In the fmi area, the outer tube is straightened during final assembly.Stresses can occur in the adhesive during straightening.With further stress (straightening) within the value stream process, the adhesive can completely detach from the steel surface and subsequently fall off.Another influence that increases the defect pattern is the production process, which is not clearly defined.Issue #2 deep dents on sheath: the dents on the distal end of the instrument are due to incorrect handling and the application of excessive force or a high probability of damage caused by an impact or fall.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: HYSTERO-RESECTOSCOPE WORKING INSERT
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18445665
• Report Number: 9610773-2024-00082
• Device Sequence Number: 17830483
• 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): 08/30/2024

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: Health Professional
• Device Model Number: A42091A
• Device Lot Number: 188W-0193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• 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