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

Catalog Number	ECH60C
Medical Device Problem Codes	Positioning Failure (1158); Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 4/28/2026 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 ech60c device was returned with no apparent damage and with a gst60t reload loaded on the device.The reload was received partially fired 1/3.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 articulated or 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 and would not knife home could not be confirmed as the device opened and closed without any difficulties noted.Once the device completed the firing sequence the knife returned home as intended.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 a98p74, 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 a semi-open thoracoscopic segmentectomy for lung cancer, it was observed that the device moved forward for one centimeter and stopped firing at the second firing between the superior and inferior lingular segments and while the lung parenchyma was resecting.The staples were partially deployed.Although the home button was pressed, the knife did not return, and the jaws could not be opened with clamping the tissue, so the hospital used the manual override lever to return and released the knife.Another device was used to complete the case.There were no adverse consequences to the patient.No additional information was provided.

• Brand Name: ECHELON
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; * 00969 ; 3035526892
• MDR Report Key: 25021540
• Report Number: 3005075853-2026-03193
• Device Sequence Number: 16064986
• Product Code: GDW
• UDI-Device Identifier: 10705036034971
• UDI-Public: (01)10705036034971(17)280731(10)A98P74
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213633
• 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
• Report Date (Section B): 04/28/2026

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: ECH60C
• Device Lot Number: A98P74
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GST60T
• Patient Sex: Unknown