MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ECHELON Flex ENDOPATH; STAPLE, IMPLANTABLE

Catalog Number	PSE60A
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, it was observed that the device would not fire.Changed to another one to continue the surgery but the same problem happened again.Changed to another four to continue the surgery, after fired, noted the staples malformed.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/7/2026.D4: batch #unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot/batch number, c9ez5j, 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.
Additional Manufacturer Narrative
(b)(4).Date sent 8/27/2026.D4 batch # 272d62.Corrected data d4: udi#.Investigation summary: the product was returned for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample revealed that the pse60a device was returned with no apparent damage, and with six cecr60g reload(b,c,d,e,f,g) present.The reload(b,d) were received fully fired, the reload(c,e,g) were received partially fired, the reload(f) was received partially fired 1/16.The returned device and reload(c,e,f,g) were tested for functionality in the straight position by resetting and reloading them into the device.The device achieved its complete firing sequence without any difficulties.The staple lines and cut lines were complete and the remaining staples meet the staple form release criteria.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness.This may have prevented the top of the knife blade assembly from entering the anvil.It is also possible that while loading the reload, the reload was pushed farther back than the reload alignment slot resulting in the knife pushing the one-piece sled forward and locking the reload.Please reference the instruction for use for more information.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 272d62, and no non-conformances were identified.

• Brand Name: ECHELON Flex ENDOPATH
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; PR 00969 ; +1(303)552-6892
• MDR Report Key: 50179876
• Report Number: 3005075853-2026-06429
• Device Sequence Number: 8281698
• Product Code: GDW
• UDI-Device Identifier: 10705036014324
• UDI-Public: (01)10705036014324(17)270813(10)C9EZ5J
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2026

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: Health Professional
• Device Catalogue Number: PSE60A
• Device Lot Number: C9EZ5J
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Supplement Date Received by Manufacturer: 08/24/2026; 08/26/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/25/2026; 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CECR60G x6
• Patient Sex: Unknown