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

Catalog Number	CDH31P
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent 10/6/2026 d4 batch # 905d08 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 cdh31p device arrived with no apparent damage along with the anvil and stapler retainer inside a plastic bag.The breakaway washer was present, uncut and the device was fully loaded with staples, indicating that the device had not been fired.No battery was received, however, when the test battery was installed the green checkmark illuminated indicated that the device was not reset.No functional test was performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the actuator was touching the stop switch actuator.In addition, a tyvek returned along with the device.This defect has been potential to a manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.A manufacturing record evaluation was performed for the finished device batch number 905d08, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: ECHELON CIRCULAR
• 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: 50144215
• Report Number: 3005075853-2026-06312
• Device Sequence Number: 13041306
• Product Code: GDW
• UDI-Device Identifier: 10705036015390
• UDI-Public: (01)10705036015390(17)290131(10)A99N6C
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2026

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: CDH31P
• Device Lot Number: A99N6C
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/25/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2026
• 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