MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ECHELON; STAPLE, IMPLANTABLE

Catalog Number	GCS40G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the stapler handle won't hold, pin keeps coming down are there any reported cases of harm from patients or users? unknown was there a significant delay? unknown.
Additional Manufacturer Narrative
(b)(4).Date sent 8/14/2026.D4 batch # 953d85.Investigation summary: the product was returned for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample determined that the gcs40g device was received with no apparent damage and with a gcr40g reload loaded in the device.However, the reload was received with the anvil and washer detached returning inside a plastic bag.The reload was received with all staples protruding, the washer uncut and with the knife recessed below the reload deck.The drivers were noted to be partially advance.The device was tested for functionality with a test reload and the device fired, forming all staples and cutting as intended.The cut line and the staple line were completed and the staples meet the staple form release criteria.The condition of the reload is consistent with the device being partially activated.As a result of the partial firing the lockout was engaged when the device was reopened.Do not fire the instrument unless the closure trigger is properly latched against the handle.The firing trigger must be pulled back completely against the closure trigger to properly fire the instrument.In addition, if the firing sequence is not complete, you could deploy the staples without cutting the washer and forming the staples.Due to the damage on the reload, it should be noted that to reload the device insert the new reload into the metal housing and snap it into position.The tracks on each side of the reload should be used as guides to align the reload within the jaws of the instrument.When the reload is properly aligned, push the reload into the instrument until it is fully seated.Remove the staple retainer.Check that the reload is held firmly within the jaws.If the reload is removed from the device, whether the reload is spent or not, and if the staple retainer has already been removed from the reload, the reload cannot be reloaded into the device.Please reference instructions for use for additional information.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 953d85, 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 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50253133
• Report Number: 3005075853-2026-06651
• Device Sequence Number: 10070204
• Product Code: GDW
• UDI-Device Identifier: 10705036027508
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K200420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: GCS40G
• Device Lot Number: A9M005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2026
• 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