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

Catalog Number	PVE35A
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laparoscopic video-assisted thoracic left lower lobectomy for lung cancer, the device was used for vessel transection.The device was used twice for pa division and the division and suturing were performed without issues.The blood vessel was taken in the jaws and fired, but at the same time, the pv was pushed outward by approximately 1¿2 mm as the staples were formed during the division of the pulmonary vein (pv).Therefore due to concerns regarding the risk of incomplete staple formation and bleeding, the jaws were opened only after ligating the proximal and distal sides with sutures.The staples had formed, but there was about 1 mm left uncut when the staple line was checked.The cartridge color was white.Additional suture was performed to complete the case.There were no adverse consequences to the patient.Additional information requested.
Additional Manufacturer Narrative
(b)(4) date sent: 8/14/2026 d4: batch #unk d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H4: the device manufacture date is currently not available.Additional information was requested, and the following was obtained: patient initials: ts gender: male pve35a was used for vessel transection during a thoracoscopic left lower lobectomy on july 21st.Two pa could be used without issues but, pv did not fix and staple formation occurred while shifting by approximately 1.5 mm toward the tip when firing on the third pulmonary vein (pv) and firing with the jaws closed.The procedure was converted from a thoracoscopic approach to an open thoracotomy and the blood vessels (central and peripheral) were ligated, and the jaw was opened.After that the operation was completed without issues.The patient was discharged on (b)(6).The doctor commented that there was a concern regarding the risk of staple malformation because pv was pushed by the knife and the staples were deployed when using pve35a during firing.There was an effect on the patient.There were adverse consequences to the patient.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: please clarify if sutures were used when the pa was divided.What is the surgeon¿s experience with the pvs device? what is the compressed width and thickness of the vessel? what is the estimated compressed width of the target vessel? did the surgeon wait 15 seconds prior to firing? did the surgeon ensure that the complete width of the compressed vessel was proximal to the cut line on the device? did the surgeon confirm that no extraneous tissue was distal to the cut line within the jaws? were any surgical clips used in the area of the device firing? were there any difficulties with the device during the initial procedure? were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe the shape and location.What was the pre and postoperative anti-coagulant and pain management protocol? was there calcification of tissue that impeded clamping or cutting? were there any pre-exiting patient conditions? what is the current status of the patient? please provide a timeline of events.No lot or batch number was provided; therefore, a device history could not be done.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
• 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: 50259138
• Report Number: 3005075853-2026-06697
• Device Sequence Number: 15983982
• Product Code: GDW
• UDI-Device Identifier: 10705036014584
• UDI-Public: 10705036014584
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141952
• 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): 08/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PVE35A
• 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: 07/31/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: VASECR35
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male