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

Catalog Number	ECH60S
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an lap appendectomy, the ech60s with white reload was was fired and stapled and cut.Then hepatics were felt and they could not open jaw, the manual release was used to bring back knife blade and open stapler.No other stapler was needed to complete.There was no patient consequence reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4) date sent: 9/25/2026 d4: batch #unk.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one ech60s device was returned with no apparent damage and with a gst60w reload loaded on the device.The reload was received partially fired 3/4.The manual override door out of position; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be used for any subsequent firings.The bailout system was reset and then, the returned device and reload were tested for functionality in the straight position by resetting and reloading it into the device.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples met the staple form release criteria.The partially fired is consistent with an incomplete or interrupted cycle.The event described of difficult to open could not be confirmed as the device opened and closed without any difficulties noted.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number a99w30, 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.

• Brand Name: ECHELON
• 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: 50899433
• Report Number: 3005075853-2026-08010
• Device Sequence Number: 16130316
• Product Code: GAG
• UDI-Device Identifier: 10705036035015
• UDI-Public: (01)10705036035015(17)290228(10)A99W30
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: ECH60S
• Device Lot Number: A99W30
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2026
• 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
• Patient Sex: Unknown