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

Catalog Number	GCR40G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, the stapler missed fired.It happened twice 4/27 and last week.There is no adverse impact on patient/user reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/9/2026 b3: exact event date unk, entered 1/1/2026 as only the year was provided.D4: batch # 850d62.Investigation summary the product was returned to ees for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the gcs40g device was received with no apparent damage and with two gcr40g reloads (b and c) present.The reload (b) was received without staples present, the washer uncut and with the knife recessed below the reload deck.Also, the drivers were noted to be partially advanced.The reload (c) was received fully fired, with the washer cut and with no apparent damage.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.Please reference instructions for use for additional information.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.Device history review a manufacturing record evaluation was performed for the finished device batch number 850d62 and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide more details about each device quality issue.Could you please confirm how many devices malfunctioned during each procedure? was the device difficult to fire? did the device fire? was the device difficult to fire? did the device cut? if the device cut/fired, was the cut line complete? did the device staple? if the device stapled/fired, was the staple line complete? if the device was stapled, was the shape of the staples (b-formation, irregular, unformed)? did the device close? did the device open? was the device difficult to close on the tissue? was the device difficult to open? on which firing did this occur? did the tissue retaining pin lock into the correct position? was there a patient consequence? if yes, how was the issue addressed? could you please clarify if there were any change in the post-operative care of the patient as a result of the event? 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 ; * ; 3035526892
• MDR Report Key: 25445764
• Report Number: 3005075853-2026-04415
• Device Sequence Number: 5751441
• Product Code: GDW
• UDI-Device Identifier: 10705036027478
• UDI-Public: (01)10705036027478(17)280630(10)850D62
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: GCR40G
• Device Lot Number: 850D62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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