MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON LINEAR CUTTER 60MM; STAPLE, IMPLANTABLE

Catalog Number	GLC60
Medical Device Problem Codes	Difficult to Insert (1316); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/15/2025.D4 batch#: 201d56.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the glc60 device was received with no apparent damage and with a glcr60b reload present.The reload had the proximal 18 double drivers up without staples, and the remaining drivers down with staples present.The returned reload had the swing tab in the locked position.Further visual analysis revealed that the wings of the reload were damaged.The damages noted on the reload are related to improper use of the device.During the visual inspection, a crack in the internal tab of the anvil shroud was noted.The crack did not have a functional impact on the device and is unrelated to the reported event.No conclusion could be reached on what caused the anvil shroud to be damaged.The reload was reset and the device was tested for functionality and it fired, cut, and formed all the remaining staples as intended.The staple line and cut line were complete and the staples meet the staple form release criteria.No difficulty was noted during firing or when installing or removing the cartridge.The event described could not be confirmed as the device performed without any difficulties and the reload could be installed and removed.The condition of the drivers up on the reload is related to improper use of the device.It should be noted that the cartridge reload is designed to lockout, as a safety feature, if any staples have been fired from the cartridge reload.In addition, failure to complete the stroke may result in incomplete staple line.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number: 201d56, and no non-conformance's were identified.Additional information was requested, and the following was obtained: what is meant by ¿reload fell from suture line¿? the last reload fell from the linear cutter.Was the device fired? 3 times.Were there any difficulties firing the device? the surgeon comment it was a little bit stiff the firing secuence.Was the reload able to fit into the device? only the last one presented problems, it did fit, but fell after the nurse charged it.
Event or Problem Description
It was reported that during a tumor resection the reload fell from the linear suture line.Change the device and reload, the procedure was successfully completed.No fragments were generated, only that the reload fell off the linear cutter.The hospital changed the device and reload, there were no patient consequences.

• Brand Name: ECHELON LINEAR CUTTER 60MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 23053313
• Report Number: 3005075853-2025-07320
• Device Sequence Number: 8685912
• Product Code: GDW
• UDI-Device Identifier: 10705036030874
• UDI-Public: (01)10705036030874(17)290630(10)201D56
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K223760
• 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
• Report Date (Section B): 09/15/2025

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: GLC60
• Device Lot Number: 201D56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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