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

Catalog Number	ECH60C
Medical Device Problem Code	Difficult to Open or Close (2921)
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 7/1/2026.D4 batch # 415d49.B3: only event year known: 2026.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 ech60c device was returned with no apparent damage and with a gst60t reload loaded on the device.The reload was received fully fired.After further analysis the articulation mechanism was noted to be damaged as would not hold the articulation setting.No functional test was performed due the condition of the device.The device was disassembled to verify the internal components and the dcr to articulation connector sub assembly was noted to be damaged.No conclusion could be reached on what caused the damage to the articulation mechanism.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.As part of our quality process, the manufacturing records of this batch number were reviewed, and the manufacturing standards were met prior to the release of this batch 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 415d49, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
It was reported that during a lobectomy procedure the stapler jaws would not open after device being closed after removal.The stapler had been fired normally 5 times.Not opening ¿ trouble shooting ¿ knife reversal, flick handle, check safety.New stapler opened.The scrub nurse then used fingers to open jaws.Patient: no harm, no change to procedure.

• 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 ; * ; 3035526892
• MDR Report Key: 25678319
• Report Number: 3005075853-2026-05158
• Device Sequence Number: 4671407
• Product Code: GAG
• UDI-Device Identifier: 10705036034971
• UDI-Public: (01)10705036034971(17)280331(10)415D49
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/01/2026

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: ECH60C
• Device Lot Number: 415D49
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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
• Patient Sex: Unknown