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

Catalog Number	ECH60L
Medical Device Problem Codes	Failure to Fire (2610); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/29/2026.B3: only event year known: 2026.D4: batch #515d27.Additional information was requested, and the following was obtained: there was no patient consequence because we cannot load the last firing.All other stapler firings looked uniform and complete showing b formation.Another like stapler was open to complete the procedure.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 without a reload present.In addition, a tyvek was received along with the sample.In addition, a 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 device event log was reviewed.The log indicates that articulation was attempted while the device was closed.Articulation function is blocked when the device is closed to prevent inadvertent patient injury.When the home button is pressed while the jaws are closed the device will attempt to retract the knife.When any of the other articulation buttons are pressed while the jaws are closed the device will provide haptic feedback indicating that articulation function is blocked.In addition, 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 device batch number 515d27, 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 gastric sleeve procedure, it was observed that the device never fired specifically on the fifth firing.For specification, there was no problem at all with the first four firings.When the tech was trying to load the fifth reload, there's a stapler reload into the jaws of the stapler, it would not fit.The tech tried several different maneuver to try to fit the reload in and it would not fit.They opened a brand new reload and attempted to try to put in the new stapler reload into the jaws of the stapler.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: 25033680
• Report Number: 3005075853-2026-03234
• Device Sequence Number: 9039844
• Product Code: GDW
• UDI-Device Identifier: 10705036034988
• UDI-Public: (01)10705036034988(17)280229(10)A97P9D
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/29/2026

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: A97P9D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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