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

Catalog Number	ECH45C
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the doctor attempted to clamp the tissue and fire but the knife did not move forward.The cartridge color was green.Another device was used to complete the case.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/13/2026.B3: unknown.D4: batch #a9856r.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 a gst45g reload loaded on the device.The reload was received partially fired 1/4.The partially fired is consistent with an incomplete or interrupted cycle.Additionally, a battery pack was received with no apparent damage and the battery pack was fully drained which is normal for a pack that has been installed into a device.After further evaluation, the bulkhead contacts were noted to be damaged.The manual override door out of position; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be articulated or used for any subsequent firings.The bailout system was reset and then, the device was tested with a test simulator for functionality in the straight position with a returned 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.The damage to the bulkhead contacts is potentially related to a manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.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.A manufacturing record evaluation was performed for the finished device batch number a9856r, 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.

• 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: 24858942
• Report Number: 3005075853-2026-02764
• Device Sequence Number: 18761032
• Product Code: GDW
• UDI-Device Identifier: 10705036034995
• UDI-Public: (01)10705036034995(17)28531(10)A9856R
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/13/2026

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: A9856R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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: GST45B
• Patient Sex: Unknown