MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON ENDOPATH; STAPLE, IMPLANTABLE

Catalog Number	EC45A
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent 5/12/2026 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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Additional information was requested, and the following was obtained: a manufacturing record evaluation was performed for lot#404dl4 provided and was found that does not correlate to any product code, could you please provide the correct lot #/batch? please provide more details about the device quality issue.Did the device deliver any staples? if yes, were the staples formed properly? if no, ask staple line issue questions if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? if yes, was there any issue with the cut line was there any difficulty opening the device jaws? if yes, what steps were taken to open the jaws.If the jaws could not be opened, how was the device removed.The correct lot number: 404d14.The stapler initially functioned normally, and two staple lines were successfully created.After that, the device stopped functioning and could not be used properly.The stapler was removed from the tissue and tested on paper for verification, at which point it no longer cut as it should.A new stapler was then taken into use and the procedure was continued.This resulted in an additional delay of approximately 5 minutes.There was no patient harm related to this event.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 unknown procedure the stapler jammed.Two cartridges were fired, and the third jammed; the jaws did not function properly.The device was removed from the abdomen and tested on paper, but the cutting function did not work.A new stapler had to be used to complete the procedure.

• Brand Name: ECHELON ENDOPATH
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 25160650
• Report Number: 3005075853-2026-03590
• Device Sequence Number: 10729370
• Product Code: GDW
• UDI-Device Identifier: 10705036001676
• UDI-Public: (01)10705036001676(17)271231(10)404D14
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K081146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2026

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: EC45A
• Device Lot Number: 404D14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 06/19/2026; 06/25/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/24/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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