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

Catalog Number	GLC100
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ileopouch surgery, when the surgeon performs the hydropneumatic test with betadine, the suture shows filtration of liquid along the entire length of the suture.The procedure was delayed by 15 minutes, manual suture was used and the procedure was completed successfully.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4) date sent: 12/31/2025 d4: batch # 187d21.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 a glcr100b loaded in the device.The reload was fully fired and no staples present.The swing tab was in locked position.Lots of loose b-form staples were noted on the cartridge deck.During the visual inspection, the internal tab of the anvil shroud was broken and a loose piece was noted.The broken shroud 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 device was tested for functionality with a test reload 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.The event could not be confirmed as the device operated without any difficulties noted.As part of ethicon¿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 187d21, and no non-conformances were identified.Additional information was requested and the following was obtained: an internal rapid response call was held with the ethicon team.The staple lines were not crossed.Experienced leakage along the entire length of the staple line.There was no issue firing the device and the surgeon feels comfortable with the device.Was there any other issue noted with the staple line other than leaking (malformed staples, staple line missing staples, etc.)? no how was the leak controlled? manual suture was there any patient consequence or change in the post-operative care of the patient as a result of the event? no, was already planned a loop ileostomy event description: in ileopouch surgery, when the surgeon performs the hydropneumatic test with betadine, the suture shows filtration of liquid along the entire length of the suture.¿ force to fire was regular ¿ no device returning ¿ was there any other issue noted with the staple line other than leaking (malformed staples, staple line missing staples, etc.)? no ¿ what anatomical structures was the device fired on? terminal ileo for pouch ¿ how was the leak addressed? manual suture ¿ was there any patient consequence or change in the post-operative care of the patient as a result of the event? no, was alredy planned a loop ileostomy ¿ what is the current patient status? the patient is well ¿ are there any photos available? no 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: 23933686
• Report Number: 3005075853-2025-09874
• Device Sequence Number: 5626007
• Product Code: GDW
• UDI-Device Identifier: 10705036030898
• UDI-Public: (01)10705036030898(17)270731(10)197D65
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/31/2025

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: GLC100
• Device Lot Number: 197D65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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