MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ETHICON; Stapler, Surgical

Catalog Number	EC3D60L
Medical Device Problem Codes	Failure to Fire (2610); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Malfunction

• Brand Name: ETHICON
• Common Device Name: Stapler, Surgical
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; PR 00969 ; +1(303)552-6892
• MDR Report Key: 50254171
• Report Number: 3005075853-2026-06654
• Device Sequence Number: 10072907
• Product Code: GAG
• UDI-Device Identifier: 10705036043546
• UDI-Public: (01)10705036043546(17)281031(10)A9944H
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K241630
• 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): 08/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EC3D60L
• Device Lot Number: A9944H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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
• Patient Sex: Unknown