MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. Echelon Linear Cutter; STAPLE, IMPLANTABLE

Catalog Number	GLC80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the product used was a glc80 with a blue reload.It was used to resect a portion of the small bowel in an emergency procedure.There were no issues during the procedure and recovery for the first 6 days was as expected.However the surgeon emailed to say the patient had a small bowel tumour resection with barcelona type anastomosis.Proven bleed from anastomosis on ct angiogram- self limiting however.Patient came back into hospital and had to have a blood transfusion.The patient has recovered.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/31/2026.D4 batch #: unknown.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.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? what surgical procedure was performed? what color setting was selected on the device and what was the sequence of the firings? what anatomical structures was the device fired on? were there any issues experienced with the device in the initial surgical procedure? was the device difficult to fire? were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe.What was the total estimated blood loss (ml)? how was the bleeding addressed other than a blood transfusion? does the surgeon believe that the bleeding was in relation to the anastomosis? what was the pre and postoperative anti-coagulant and pain management protocol? 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.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 Linear Cutter
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): 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: 50097822
• Report Number: 3005075853-2026-06039
• Device Sequence Number: 18721495
• Product Code: GDW
• UDI-Device Identifier: 10705036030881
• UDI-Public: 10705036030881
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223760
• 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): 07/31/2026

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: GLC80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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