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

Catalog Number	PVE35A
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 8/28/2026.D4: batch #unk.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: what were the indications for surgery? what surgical procedure was performed? 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 or staple formation during the initial procedure? how was the post-op bleeding identified? how many days postoperative was the bleeding identified? what was the total estimated blood loss (ml)? was a transfusion required? 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? any clips, clamps, or graspers near the area where the device was being fired? what is the current status of the patient? what is meant by ¿failed to function correctly¿.Can more information be provided? what is meant by ¿anterior row of metallic clips¿? was it left side or right side of the staple line? please provide a timeline of events.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 pve35a lot number a99n25 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 an unspecified surgical procedure, it was observed that the stapler malfunctioned following application to the renal vein.According to the report, the anterior row of metallic clips failed to function correctly, resulting in significant bleeding and requiring conversion to open surgery.The current status of the patient is unknown.Additional information requested.

• 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: 50500187
• Report Number: 3005075853-2026-07171
• Device Sequence Number: 21197081
• Product Code: GDW
• UDI-Device Identifier: 10705036014584
• UDI-Public: (01)10705036014584(17)290131(10)A99N25
• 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): 08/28/2026

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
• Device Lot Number: A99N25
• 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: 08/16/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Unknown