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

Catalog Number	EC60A
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/29/2026.D4: batch#: 632d49.Additional information was requested, and the following was obtained: 1.What steps were taken to open the jaws.Unknown.2.If the jaws could not be opened, how was the device removed.The tissue was cut off.Removed the device directly.3.Did the device eventually open? unknown.4.Regarding "changed another one to use, still could not fire", please clarify if other device (stapler/reload) was used? changed a new stapler and a new reload.However, could not fire.Changed a new reload again to continue the surgery.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 ec60a device was received for analysis with no apparent damaged and with a cecr60w reload loaded on the device, and a cecr60b reload(b) present.Both reloads were received fully fired.The device with the closing trigger and anvil in the closed position, and the firing mechanism in the return stroke with the knife not fully back.In addition, a clip was found lodged behind the knife, resulting in the firing mechanisms jamming.The device was reset and tested for functionality in the articulated position with a test reload.The device achieved its complete stroke 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.To mitigate the potential for staples getting into the cartridge and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and cartridge jaw in sterile solution and then wipe the anvil and cartridge 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.As part of ethicon ¿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: 632d49, 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 laparoscopic radical gastrectomy procedure; it was observed that the device would not fire when severing duodenal tissue on the first firing.It was further reported that they could not open the jaw.As the tissue was cut off, they removed the device from the patient through tissue gap.Changed another one to use, still could not fire.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: ECHELON FLEX ENDOPATH
• 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: 25337509
• Report Number: 3005075853-2026-04096
• Device Sequence Number: 12085105
• Product Code: GDW
• UDI-Device Identifier: 10705036001706
• UDI-Public: (01)10705036001706(17)280520(10)632D49
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: EC60A
• Device Lot Number: 632D49
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2025
• 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: CECR60B.; CECR60W.
• Patient Sex: Unknown