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

Catalog Number	CDH23P
Medical Device Problem Codes	Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent: 6/19/2026 d4: batch # 790d50.Investigation summary the product was returned to ethicon endo-surgery for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample revealed that the cdh23p device arrived with no apparent damage.The washer was present and uncut and there were staples present.When the test battery was installed the tissue compression scale backlight was illuminated.However, the green checkmark was not illuminated, indicating that the device was not fired.The device was tested for functionality with the returned washer and a test battery and it fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident.The staple line was complete, and the staples meet the staple form release criteria.The event described could not be confirmed as the device fired without any difficulties noted and it was returned without detectable damage.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review a manufacturing record evaluation was performed for the finished device batch number 790d50, and no non-conformances related to the reported complaint condition were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What were the indications for surgery? did the patient receive any preoperative chemotherapy or radiation? what healthcare professional fired the device and what is his/her experience with the device? where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? were there any issues with device use/firing? was there any difficulty removing the device? were there any issues noted with staple formation? if so, please describe the shape and location.Does the surgeon believe the post-operative complications were related to an alleged deficiency of the device or were there other contributing factors to include patient tissue condition? what lead to the change in technique vs grabbing another circular powered stapler? 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, during esophagojejunostomy, during use for esophagojejunostomy, the indicator was illuminated, but the device could not be fired.Due to a change in the anastomotic technique for the esophagojejunostomy (from circular procedure to overlap procedure using an end cutter), additional resection was required and the operation time was prolonged.No further information is available.

• 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: 25561448
• Report Number: 3005075853-2026-04758
• Device Sequence Number: 18721815
• Product Code: GDW
• UDI-Device Identifier: 10705036015369
• UDI-Public: (01)10705036015369(17)280930(10)A9922C
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: CDH23P
• Device Lot Number: A9922C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• 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: Female