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

Catalog Number	GCS40G
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Cut (2587); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/15/2026.D4: batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device gcs40g lot number a98m0p and no non-conformances were identified.Additional information was requested and the following was obtained: was the device difficult to fire? no did the device fire? yes was the device difficult to fire? no did the device cut? yes, cut.But it didin´t cut or staple it in the middle of tissue.If the device cut/fired, was the cut line complete? no did the device staple? yes, but in the middle of tissue not if the device stapled/fired, was the staple line complete? no if the device was stapled, was the shape of the staples (b-formation, irregular, unformed)? unknow did the device close?yes did the device open?yes was the device difficult to close on the tissue? no was the device difficult to open? no on which firing did this occur? the only firing.Did the tissue retaining pin lock into the correct position? yes was there a patient consequence? if yes, how was the issue addressed? there was´t any consequences to the patient, but the doctor ordered a new device, a same one, to close the tissue for complete.And then, all the tests was performed by the doctor to ensure that the tissue was stapled for complet whith the new one.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event? i don´t know nothing about the post-operative.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.
Event or Problem Description
It was reported that during a rectum procedure, opening of the staple line of the rectus muscle after firing.No patient consequences were reported.

• Brand Name: ECHELON
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 25184899
• Report Number: 3005075853-2026-03691
• Device Sequence Number: 13435006
• Product Code: GDW
• UDI-Device Identifier: 10705036027508
• UDI-Public: (01)10705036027508(17)280731(10)A98M0P
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2026

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: A98M0P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 05/20/2026; 06/19/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/11/2026; 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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
• Patient Age: 45 YR
• Patient Sex: Unknown