MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON CIRCULAR; STAPLE, IMPLANTABLE

Catalog Number	CDH31P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Post Operative Wound Infection (2446)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent: 2/24/2026 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.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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional information: do the surgeons fire the device or someone else? the surgeon but unsure about the other surgeon do they use any purse string or other techniques? unsure they used to use manual and transition to manual? they used to use medtronic and switched to jnj do they wait 15 seconds during dialing down? they have been in-service and have the ifu.Unsure of actual practice.Have they seen any malformed staples? unsure how do they conduct their leak test? the anastomosis have all passed the leak tests when was the last time they saw the surgeon actually fire the device in a case? they do not want case support.Are they crossing staple lines? unsure what technique do they use to remove the device? unsure what is the doctors' goal? 1 surgeon.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.
Event or Problem Description
It was reported that an anastomotic leak occurred following a robotic laparoscopic anterior resection procedure.The device used during the procedure was discarded and is not available for return or evaluation.No other information available.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/6/2026.Additional information was requested and the following was obtained: an external rapid response call was held to include post market surveillance, customer quality, quality engineering, quality, design engineering, marketing, the local team, and the operating surgeon to discuss the complaint.The surgeon has experienced an increase in surgical site infections due to anastomotic leaks.When using the device, he has experienced issues with the ease of use of the device, compression of the tissue, and ease of extraction.The surgeon indicated he always is pulling during an extraction; it has never been smooth.There is always tension.His current process for division and anastomosis is usually the triple staple technique and, at times, the side-to-side anastomoses.The resident, pa or the surgeon, himself, always does the device firing.They have tried many different techniques.Procedures are being minimally invasive.It is putting undue stress on the anastomosis, which is already delicate.Having to stretch the anastomosis is the main issue for the surgeon.

• Brand Name: ECHELON CIRCULAR
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 24433125
• Report Number: 3005075853-2026-01585
• Device Sequence Number: 10297606
• Product Code: GDW
• UDI-Device Identifier: 10705036015390
• UDI-Public: 10705036015390
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CDH31P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown