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

Catalog Number	GLC80
Medical Device Problem Code	Unintended Compatibility (4047)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the glc linear cutter broke from the anvil part.Unable to fire the cartridge.Was there any reported patient or user harm? no.Was there a significant delay? no.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/17/2026.D4 batch # 887d00.Investigation summary.The product was returned for evaluation.Visual inspection was conducted on the returned device.Visual examination of the returned glc80 device identified the knob in the forward position.The anvil was found broken and remained attached only by the anvil insert.Damage was also noted on the anvil shroud tab.No reload was available for evaluation.Due to the condition of the device no functional test was performed.No conclusion could be reached as to how the metal anvil became broken.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 887d00, and no non-conformances were identified.

• 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: 50802482
• Report Number: 3005075853-2026-07637
• Device Sequence Number: 10589700
• Product Code: GAG
• UDI-Device Identifier: 10705036030881
• UDI-Public: (01)10705036030881(17)291231(10)887D00
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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

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: GLC80
• Device Lot Number: 887D00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2026
• 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
• Patient Sex: Unknown