MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CIRCULAR MECH XL SEAL 25MM; STAPLE, IMPLANTABLE

Catalog Number	ECS25B
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 2/24/2025.D4 batch #793c98.Investigation summary- the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the ecs25b device arrived with no apparent damage.The breakaway washer was present, cut and there were no staples present, indicating that the device achieved a full firing stroke.In addition, the washer and knife were noted to have slight nicks.The damage on the knife and washer is consistent when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.Please reference the instruction for use for more information.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident.The staple line was complete, and the staples meet the staple form release criteria.Additionally, two photos were provided and it showed: the first photo shows what appear to be a malformed staple on the tissue along with some surgical instruments.The second photo shows a device with small piece of tissue between the anvil and guide face.Please refer to product code table.The event described could not be confirmed as no closing issues were noted and the device performed without any difficulties when the orange staple height indicator moves into the green range.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: orange staple height indicator is fully within green range.If excessive force is required to close the device, this may indicate there is too much tissue or thickened tissue in the device.Attempting to fire the device in this condition may result in malformed staples, incomplete cut line, bleeding, and leakage from the staple line and/or difficulty removing the device.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 793c98, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a lap gastric bypass the circular stapler didn't fully close.The surgeon has only noticed after firing.The surgeon oversewed the staple line, as he couldn't evaluate whether the staples had formed as they should.Test with blue contrast fluid was ok.The procedure was successfully completed.There were no patient consequences.

• Brand Name: CIRCULAR MECH XL SEAL 25MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21448198
• Report Number: 3005075853-2025-01424
• Device Sequence Number: 7761035
• Product Code: GDW
• UDI-Device Identifier: 10705036022923
• UDI-Public: (01)10705036022923(17)281231(10)793C98(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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 Catalogue Number: ECS25B
• Device Lot Number: 793C98
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown