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

Catalog Number	GCS40G
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a rectum procedure, after stapling the distal rectum with contour stapler, i proceeded to anastomosis straight lap with circular stapler, but when inserting and locating the circular stapler, there was a total opening of contour staples, requiring the manual closure of the distal rectum.Then we proceeded rectal anastomosis with circular stapler which was not satisfactory, and it was necessary to perform protective colostomy.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/7/2026.D4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.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 is the current status of the patient? was the patients post operative care altered in any way due to the alleged deficiency with the devices? 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? when was the staple retaining cap removed? what provisions did the surgeon take to ensure the tissue was lying evenly within the jaws? can more information be provided about staple form? was the device difficult to close? was the device closed and repositioned multiple times prior to firing? was the device difficult to fire? was the distal transection completed in one or multiple firings? what is the scrub's experience with reloading the device? were there any difficulties loading the device? what did they do to ensure that the cartridge was snapped in please prior to closing the device? was the retaining pin placed manually or automatically? 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
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 25736390
• Report Number: 3005075853-2026-05348
• Device Sequence Number: 13375459
• Product Code: GDW
• UDI-Device Identifier: 10705036027508
• UDI-Public: (01)10705036027508(17)290131(10)A99P7E
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K200420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: GCS40G
• Device Lot Number: A99P7E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2026
• 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 Age: 66 YR
• Patient Sex: Unknown