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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/10/2025.D4: batch #176d81.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 ntlc55 device was received with the anvil partially detached on the distal end and the anvil post on this area appears to be damaged as if the anvil was pulled out of the device.A reload was returned along with the device and it had the proximal 2 drivers up with partially formed staples in the pockets, the remaining drivers down with staples present and the swing tab in the locked position.In addition, 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 event reported was confirmed and due to the condition of the anvil, 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.For the drivers up, 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 176d81, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
It was reported that during an unknown procedure, the firing knob was stiff, so it 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.

• 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: 23772286
• Report Number: 3005075853-2025-09370
• Device Sequence Number: 10562791
• Product Code: GDW
• UDI-Device Identifier: 10705036002611
• UDI-Public: (01)10705036002611(17)290831(10)176D81
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/10/2025

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: NTLC55
• Device Lot Number: 176D81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SR55
• Patient Sex: Unknown