MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON LINEAR CUTTER 100MM; STAPLE, IMPLANTABLE

Catalog Number	GLC100
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, the glc staple line was not fully cut through - unclear if the distance between staple & cut line is the intended 9mm or caused by an incomplete knife blade advancement.No significant resistance in closing and firing of stapler.Case proceeded with a second reload.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/12/2026.B3: exact event date unk, entered 1/1/2025 as only the year was provided.D4: batch # 466d87.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the glc100 device was received with no apparent damage and three (3) glcr100b reloads in a separate bag.Reload (a) had 42 proximal double drivers up without staples, and the remaining drivers down with staples present.Reloads (b) & (c) were received fully fired.All three (3) reloads had swing tab in locked position.Additionally, two photos were provided and it showed the condition of the reported event.During the visual inspection, the internal tab of the anvil shroud was noted to be broken.The broken shroud tab did not have a functional impact on the device.No conclusion could be reached on what caused the anvil shroud to be damaged.The event reported was confirmed and it 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.Device history review: a manufacturing record evaluation was performed for the finished device batch number 466d87, and no non-conformances were identified.Additional information was requested and the following was obtained: i¿ve spoken to her about the 9mm difference between staple and cut lines after her feedback.Submitted this pc because she says she was unable to determine if the difference was indeed 9mm.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 100MM
• 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: 24035701
• Report Number: 3005075853-2026-00349
• Device Sequence Number: 13014282
• Product Code: GDW
• UDI-Device Identifier: 10705036030898
• UDI-Public: (01)10705036030898(17)280531(10)624D81
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/12/2026

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: GLC100
• Device Lot Number: 624D81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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