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

Catalog Number	ECH45C
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, during cartridge loading, the cartridge could not be loaded into the jaw properly.Another new echelon could load the same cartridge with no problem, and the device could be used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent 6/2/2026.D4 batch #a98z2y.H11 = b3: unknown; captured as awareness date.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 without a reload present.In addition, a reload pan was found lodged inside the channel.The pan was removed from the channel and the device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.It is possible that handling by the customer could dislodge the pan.Dislodgement as a result of the removal of the reload from the device is the most likely scenario.Please reference the instruction for use for more information.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.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 a98z2y, and no non-conformances were identified.

• 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: 25363507
• Report Number: 3005075853-2026-04203
• Device Sequence Number: 10654565
• Product Code: GAG
• UDI-Device Identifier: 10705036034995
• UDI-Public: (01)10705036034995(17)280930(10)A98Z2Y
• 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): 06/02/2026

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: A98Z2Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2025
• 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