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	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery ,the device could not be fired.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent 8/31/2026 d4 batch # 855d32 b3: unknown; captured as awareness date 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, with a reload loaded in the device and the firing knob forward.The reload had the proximal 7 drivers up, the remaining drivers down with staples present and a swing tab in the locked position.In addition, the knife was not completely within the doghouse component.The knife returned manually to inside the doghouse, and reload swing tab was reset in order to fire the cartridge.However, the firing sequence was not completed, leaving eight drivers in the down position near the end of the firing path.The pan was removed and upon disassembly of the cartridge, damage was identified on one of the knife assembly legs, which is considered the likely cause of the incomplete firing condition.Additionally, damage was observed on the underside of the cartridge along the path where the knife assembly legs pass through.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.It is possible that the knife exposed noted on the reload is consist with the firing knob was not returned completely prior to opening the device causing that the knife not returned completely to its home position.Please refer instructions for use.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 855d32, 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: 50524599
• Report Number: 3005075853-2026-07257
• Device Sequence Number: 5976615
• Product Code: GDW
• UDI-Device Identifier: 10705036002628
• UDI-Public: (01)10705036002628(17)311231(10)855D32
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/31/2026

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: 855D32
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2026
• 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