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

Catalog Number	PSEE60A
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Cut (2587); Failure to Fire (2610); Difficult to Open or Close (2921); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/25/2026 d4: batch #unk investigation summary: this is an analysis of two videos submitted to ethicon endo-surgery for evaluation.During the visual analysis, the following was observed: the first video shows the device jaws closed on the tissue through a trocar.The trocar is inserted up to the 60 line on the jaws; it appears the anvil has only the distal part positioned on the tissue while the proximal part is not positioned on tissue.- at 00:05 the device fires and the cartridge drivers are seen to lift.- at 00:08 the tissue appears to shift slightly.- at 00:18 the anvil appears to open slightly.However, due to tissue on staples line proper/improper form of staples cannot be determined.The second video shows the device jaws with a blue cartridge fully fired inside the body cavity.Several b-formed staples are visible on the cartridge deck and on the anvil.Based on the videos the event described could not be confirmed.As part of ethicon endo-surgery quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: ECHELON FLEX
• 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: 50820586
• Report Number: 3005075853-2026-07698
• Device Sequence Number: 10210600
• Product Code: GDW
• UDI-Device Identifier: 10705036014607
• UDI-Public: (01)10705036014607(17)270731(10)C9EV7X
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: PSEE60A
• Device Lot Number: C9EV7X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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