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

Catalog Number	CDH29P
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent; 9/22/2026 additional information was requested, and the following was obtained: 1: was the patient¿s tissue particularly thick/fibrous/irradiated? yes 2: did the patient receive any pre-op radio/chemotherapy? yes 2: did the person closing the anvil/winding it down find a lot of resistance/it was difficult to close? no 3: where was the orange indicator within the green range before firing ¿ top, middle or bottom? three -quarters, towards bottom 4: was an illuminated green tick/checkmark observed after firing (above the tissue/staple closure range window)? yes 5: did there appear to be any issues when firing the device? no 6: how much resistance was felt when removing the gun with anvil from the rectum ¿ was the device easy to remove? minimal 7: did you observe 2 complete donuts after the device was removed from the patient? yes ¿ confirmed on histology 8: did you observe the white washer had been separated into 2 when observing the donuts still attached to the anvil/spike? yes 9: when you observed the donuts and scoped the patient, had the stapler appeared to cut as expected, completely circumferentially around the entire staple line? yes 10: i understand the patient then had to have an apr as the resection was too low to further resect and attempt to join again.Please can you confirm if the patient now has a permanent stoma? yes permanent stoma 11: please could you advise of any increased length of stay above what you would have expected from the planned anterior resection? difficult to know if related to difference from planned operation 12:please could you advise of the current status of the patient? patient is home and well.

• 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: 50571813
• Report Number: 3005075853-2026-07367
• Device Sequence Number: 18610143
• Product Code: GDW
• UDI-Device Identifier: 10705036015383
• UDI-Public: 10705036015383
• 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): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CDH29P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/25/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/22/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown