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

Catalog Number	CDH25P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Inflammation (1932)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a sigmoid resection procedure, the surgeon experienced an anastomotic leak where powered circular devices were utilized.One patient required a return to the operating room for a subsequent procedure.The patient experienced postoperative leak resulting in inflammation.
Additional Manufacturer Narrative
(b)(4).Date sent 8/11/2026.D4 batch # unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.B3: only event year known: 2026.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.Additional information was requested, and the following was obtained: what is the product code? it is believed to be either cdh25p or cdh29p.What were the indications for surgery? unsure of question.What surgical procedure was performed? sigmoid colon resection.Did the patient receive any preoperative chemotherapy or radiation? no low.Were there any issues experienced with the device in the initial surgical procedure? no.What healthcare professional fired the device and what is his/her experience with the device? been a user since the device came to market.Where in the green gap setting scale was the inoicator located prior to firing (low-b, middle-b, or high-b)? low b.Did the healthcare professional wait 15 seconds aftyes, losing the device and then retighten prior to firing? yes.Were there any issues with device use/firing? no.What confirmation was received that the device completed the firing sequence? green check.Was the green checkmark visible at the end of the firing? yes.How many counter-clockwise revolutions of the adjusting knob were used to open the device? 2.Was there any difficulty removing the device? no.Was a complete transection of the white breakaway washer visually confirmed? yes.Were the donuts inspected? if so, please describe.Yes, two complete donuts.Were there any issues noted with staple formation? if so, please describe the shape and location.Not observed.How many days postoperative did the leak occur? unknown.How was the leak identified? infection.What was observed at the site of the leak upon reoperation? unknown.How was the leak addressed? oversew.What is the current status of the patient? unknown.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: 50207892
• Report Number: 3005075853-2026-06483
• Device Sequence Number: 10437189
• 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: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: CDH25P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/11/2026
• 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