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

Catalog Number	LONG60A
Medical Device Problem Codes	Mechanical Jam (2983); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/9/2026.D4: batch #.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished long60a, with lot/batch number a9937h, 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 sleeve gastrectomy procedure, a cracking sound was heard at first firing.Staple line and cut were finished and solid, but the knife did not come back.The surgeon was able to remove the stapled tissue without damage, but oversewed for safety reasons.A new stapler was used to complete the procedure with a delay of five minutes.There was no patient consequence reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/11/2026.D4: batch #807d27.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 the long60a device was received for analysis with no apparent damage, the knife in the home position and with a cartridge loaded on the device.The reload returned fully fired.Further analysis showed that the clamping mechanism was noted to be non-functional as the release button was stuck and the device could not be opened.No further functional testing could be performed due to the condition of the device.The device was disassembled to verify the integrity of the internal components and the release button was noted to be cracked.In addition, the pin of the release button was removed and the button released without difficulty.No conclusion could be reached on what cause the reported event.It is possible that the noise that was heard came from the button when it was damaged.One possible scenario for the described event is due to applying a large prying force on the closure trigger handle in the opening direction.This can then result in damage to the release button if the applied load is high enough.As part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meet the required specifications prior to shipment.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 807d27, and no non-conformances were identified.

• Brand Name: ECHELON ENDOPATH
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 24832114
• Report Number: 3005075853-2026-02702
• Device Sequence Number: 10447086
• Product Code: GDW
• UDI-Device Identifier: 10705036002444
• UDI-Public: (01)10705036002444(17)281031(10)A9937H
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: LONG60A
• Device Lot Number: A9937H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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: Female