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

Catalog Number	ECH45C
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Cut (2587); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 10/02/2026.D4: batch #388d29.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 ech45c device was returned with no apparent damage, with a tyvek, and with no reload present.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The cut line was completed and the staples met the staple form release criteria.However, the knife was noted to have nicks.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object, or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.The event described of short cut or absent cut could not be confirmed as no short cut-absent cut was noted during functional testing.The device event log was reviewed.The log indicates that no suspect power cycles were 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 388d29, and no non-conformances were identified.

• 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: 50845453
• Report Number: 3005075853-2026-07811
• Device Sequence Number: 13323940
• Product Code: GAG
• UDI-Device Identifier: 10705036034995
• UDI-Public: (01)10705036034995(17)271231(10)A9748A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213633
• 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): 09/21/2026

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: ECH45C
• Device Lot Number: A9748A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/21/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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