MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 55MM SELECTABLE NEW TLC; STAPLE, IMPLANTABLE

Catalog Number	NTLC55
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk surgery, the knife failed to advance beyond the one-third position.The procedure was not delayed and completed successfully.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/5/2026.D4: batch # u5af3g.Investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the ntlc75 device was receiveda with loose knob in the home position; however, the device remained functional and a sr55 reload loaded.The reload was received with the knife not fully seated within the doghouse.Additionally, the proximal three drivers were in the up position while the remaining drivers were down, with staples present and the swing tab in the locked position.Further analysis revealed that the lockout spring was missing and not returned with the device, which explains the loose knob condition.Damage was also observed on the shroud at the location where the pin connects the metal component to the shroud, indicating that the metal part had been manipulated or reassembled.The reload swing tab was reset in order to fire the cartridge.The device was tested with the returned reload and fired without any difficulties.The staple line was complete, and the staples meet the staple form release criteria.The batch number on the device and reload showed that the sample was expired as of 2025.While we have no reason to believe this contributed to the reported event, it should be noted that the device returned appears to have been used after the expiration date.Due to the condition of the channel shroud, knife exposed drivers up on the reload, the reported complaint was confirmed by an external cause as improper handling.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.It is possible that the knife exposed noted on the reload consist of the firing knob was not returned completely prior to opening the device causing that the knife not to return completely to its home position.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 u5af3g, and no non-conformances related to the reported complaint condition were identified.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: 55MM SELECTABLE NEW TLC
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 24270424
• Report Number: 3005075853-2026-01057
• Device Sequence Number: 21500135
• Product Code: GDW
• UDI-Device Identifier: 10705036002611
• UDI-Public: (01)10705036002611(17)250228(10)U5AF3G
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K092577
• 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): 02/05/2026

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 Expiration Date: 02/28/2025
• Device Catalogue Number: NTLC55
• Device Lot Number: U5AF3G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2020
• 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