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

Catalog Number	CDH25P
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent 8/31/2026.D4 batch # 947d93.Corrected data d4: udi#.Investigation summary.The product was returned for thorough evaluation, which included visual inspections of the returned device.Visual analysis of the returned sample determined that the cdh25p device was received with no apparent damage and the anvil was not returned for analysis.Only casing half washer was returned and there were no staples present.When the test battery was installed was noted difficulty to insert the battery and the green checkmark illuminated, indicating that the device was fired and achieved complete firing stroke.The device was disassembled to verify the condition of the internal components and the bulkhead contact from the left side was noted to be damaged.In addition, marks and damages on the bulkhead shroud were noted possibly caused by improper battery loading.This condition may have caused the reported event.Although no conclusion could be reach on the cause of the reported event, it should be noted that when insert the battery pack, aligning the release tabs with the slots situated on the back of the device.Ensure that it is completely engaged; a clear click sound will confirm it¿s properly secured, and the backlight of the tissue compression scale will glow.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 947d93, 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: 50236615
• Report Number: 3005075853-2026-06615
• Device Sequence Number: 16050371
• Product Code: GDW
• UDI-Device Identifier: 10705036015376
• UDI-Public: (01)10705036015376(17)290228(10)947D93
• 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,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2026

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: CDH25P
• Device Lot Number: 947D93
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: Not provided; 08/21/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 08/24/2026; 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2026
• 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