MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	NTLC75
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the scrub nurse properly loaded the cartridge to the body upon odp guide, but the surgeon was unable to fire the new tlc stapler all the way in order to transect the tissue.Was surgery delayed due to the reported event? no.Was procedure successfully completed? unknown.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.
Additional Manufacturer Narrative
(b)(4).Date sent 8/10/2026.D4 batch # 381d02.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 determined that the ntlc75 device was received with no apparent damage and with a sr75 reload no loaded in the device.In addition, a tyvek was received along with the sample.The reload had the proximal 10 drivers up and the remaining drivers down with staples present and the swing tab in the locked position.Also, the gripping surfaces from right side was damaged marking the reload nonfunctional.The device was tested for functionality with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete, and the staples meet the staple form release criteria.The event reported was confirmed and it is related to improper use of the device.It should be noted that the 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 an 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 381d02, and no non-conformances were identified.

• Brand Name: N/A
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): 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: 50197280
• Report Number: 3005075853-2026-06466
• Device Sequence Number: 18750941
• Product Code: GDW
• UDI-Device Identifier: 10705036002628
• UDI-Public: (01)10705036002628(17)291031(10)344D18
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K092577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: NTLC75
• Device Lot Number: 344D18
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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