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

Catalog Number	ECH60S
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a partial pneumonectomy, the unusual battery sound continued after the stapling was completed.There was no issue with the stapling.There was no effect on the patient.The same device was used as is to complete the case.There were no adverse consequences to the patient.One device will be returning.No cartridge was loaded in the retuned device.No additional information was provided.
Additional Manufacturer Narrative
(b)(4) date sent: 9/18/2026 d4: batch #a98m6u.Additional information was requested, and the following was obtained: the surgeon commented that the resected lung tissue was not particularly thick.Two gst60g was received from the operating room and this information was added.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 two gst60g reloads present.The reload (b) was received fully fired with no apparent damage.The reload (c) was received fully fired; upon further inspection, the reload was found to have damaged on the knife channel.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples met the staple release criteria.The found damage on the reload is consistent when the device is fired over an already existing staple line; when this happens it is possible that the knife may push the staple line and tissue forward shaving the reload knife channel.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 non specific noise could not be confirmed as no abnormal noises were 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 lot/batch number, a98u12, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number a98m6u, 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: 50820415
• Report Number: 3005075853-2026-07696
• Device Sequence Number: 10713103
• Product Code: GAG
• UDI-Device Identifier: 10705036035015
• UDI-Public: (01)10705036035015(17)280831(10)A98U12
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/18/2026

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: A98U12
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• 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