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

Catalog Number	ECH45C
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 4/29/2026 d4: batch #571d91.Additional information was requested, and the following was obtained: during pre-testing, the device was stuck.Due to failure to form properly, the lung tissue was bleeding from the incomplete staple line.Hcp did the treatment during procedure.No patient consequence occurred and patient left the hospital already.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 ech45c device was returned with no apparent damage and with three reloads present.The gst45d reload (b) was received unfired.The gst45d reload (c) was received fully fired.Upon further inspection, the reload was found to have damaged on the knife channel.The gst45g reload (d) was received fully fired and with damage on reload deck.The device was tested for functionality in the straight position with the returned reload (b) and achieved its complete firing sequence without any difficulties.The cut line was completed and the staples meet the staple form release criteria.However, the cut was noted to be jagged due to a damaged knife.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object, or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.The damage to the reload is consistent with the device being clamped over a hard object.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload 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.The device event log was reviewed.The log indicates that the device had a high force to fire for one of the clinical firings, indicating that the device was firing over an obstruction, or too thick of tissue.In addition, 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.Additionally, videos were provided and they showed the condition of the reported event.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 lot/batch number, a9817l, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 571d91, and no non-conformances related to the reported complaint condition 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 an unspecified surgical procedure, the same echelon 3000 was fired with two reloads without any difficulty.However, for following firing, the staple did not come out and tissue was not cut.The third reload was gst45d, the fourth reload was gst45d, and the fifth reload was gst45g.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: 25028388
• Report Number: 3005075853-2026-03214
• Device Sequence Number: 10133917
• Product Code: GDW
• UDI-Device Identifier: 10705036034995
• UDI-Public: (01)10705036034995(17)280430(10)A9817L
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/29/2026

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: ECH45C
• Device Lot Number: A9817L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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: GST45D(X2); GST45G
• Patient Sex: Unknown