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

Catalog Number	CDH25P
Medical Device Problem Codes	Failure to Form Staple (2579); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unknown surgery, there have been report of difficulty in removing, and the staples that had unformed were found at the anvil.The customer inquired about whether that might be the cause.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/27/2026.B3: unknown; captured as awareness date.D4 batch #: unknown.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Additional information was requested and the following was obtained: the case involved sigmoid colon surgery.There were no abnormalities in operating or closing the knob or other controls.There was no significant bleeding or tissue damage.No additional treatment was performed for the area where the staples were not properly formed.However, there was some difficulty in removing the device.Staple malformation was observed on the resected specimen side.No change in the surgical procedure was made during additional suturing/re-suturing.The patient is stable.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 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: 50038654
• Report Number: 3005075853-2026-05956
• Device Sequence Number: 9853423
• Product Code: GDW
• UDI-Device Identifier: 10705036015376
• UDI-Public: 10705036015376
• 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
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/04/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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