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

Catalog Number	PLE60A
Medical Device Problem Codes	Failure to Cut (2587); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a gastroplasty procedure, it was observed that the device had an unspecified malfunction.There was no patient consequence nor surgical delay reported.Additional information requested.
Additional Manufacturer Narrative
(b)(4) date sent: 9/17/2026 d4: batch #unk h4; unknown.Additional information was requested, and the following was obtained: we hereby inform you of the occurrence of a technical failure involving surgical staplers used during colectomy and gastroplasty procedures, performed at the surgical center of the.During the procedures, the device was activated with the purpose of stapling and sectioning the tissue.After activation, it was observed that the stapler closed the staples, but did not section the tissue, remaining locked.In view of the impossibility of opening the device by the usual mechanism, an attempt was made to open it manually, without success.It was then necessary to use surgical forceps to promote the forced opening of the stapler, allowing its removal.Due to the intercurrence and the impossibility of using the device initially used, it was necessary to open a new surgical stapler to continue the procedure.In view of what happened, we request the technical evaluation of the device, as well as the position of this company regarding the occurrence and the appropriate measures, including the analysis of the unit involved and the verification of possible recurrence of the problem in other devices of the same batch.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: per aei received it states "we hereby inform you of the occurrence of a technical failure involving surgical staplers used during colectomy and gastroplasty procedures, performed at the surgical center of the (please refer to the attached mail).During the procedures".Please clarify the following: can you please confirm whether the previous events mentioned were reported to ethicon? if yes, could you please provide the corresponding product complaint (pc) number(s)? did those prior events involve the same device? approximately how many times has the surgeon observed this same issue? did any of the prior events result in patient impact or require a change to the procedure please confirm lot number 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.

• 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: 50807215
• Report Number: 3005075853-2026-07668
• Device Sequence Number: 15616542
• Product Code: GDW
• UDI-Device Identifier: 10705036014300
• UDI-Public: (01)10705036014300(17)260531(10)A9D90C
• 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
• Report Date (Section B): 09/17/2026

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 Expiration Date: 05/31/2026
• Device Catalogue Number: PLE60A
• Device Lot Number: A9D90C
• 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: 09/01/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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