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

Catalog Number	ECH60L
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/24/2026 d4: batch # 409d25.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 ech60l device was returned with no apparent damage and with three gst60w reloads present.The reload (b) was received fully fired.The reload (c) was received unfired.The reload (c) was received fully fired with the pan detached from the reload.In addition, the reload pan was found lodged inside the channel.The pan was removed from the channel and 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.It is possible that handling by the customer could dislodge the pan.Dislodgement as a result of the removal of the reload from the device is the most likely scenario.The event log was reviewed.An event was found that typically indicates that the knife encountered the firing safety lockout mechanism.This mechanism ensures that the knife cannot deploy without an unfired reload installed.It is possible that it occurred due to improper installation of the reload.Always ensure that the retaining cap is in place when a reload is installed into a device.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 ech60l, with lot number a97v40, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 409d25, 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 unknown procedure, it was observed that the device did not fire.There was no patient consequence nor surgical delay reported.No additional information 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: 25612979
• Report Number: 3005075853-2026-04949
• Device Sequence Number: 18395189
• Product Code: GAG
• UDI-Device Identifier: 10705036034988
• UDI-Public: (01)10705036034988(17)280331(10)A97V40
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: ECH60L
• Device Lot Number: A97V40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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