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	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 5/25/2026 d4: batch # 473d10.Investigation summary the product was returned to ees for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the device was received with no apparent damage and with a reload present.The reload had the proximal 2 drivers up without staples, and the remaining drivers down with staples present.The returned reload had the swing tab in the locked position and it was received along with its opened packaging.The reload swing tab was reset in order to fire the cartridge.The device was tested for functionality with the returned reload and fired without any difficulties however, the staple line at the distal end showed that one staple was malformed.No conclusion could be reach on what caused the condition of malformed staples.The event reported was confirmed and it is related to improper use of the device.It should be noted that the cartridge 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 incomplete staple line.Please reference the instruction for use for more information.As part of ees 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 473d10, and no non-conformances 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.
Event or Problem Description
It was reported that during an unk procedure, upon placing the ntlc75 and sr75 on the bowel, the surgeon encountered difficulty firing the device and the device could not be fired.A new reload was opened and reloaded to the ntlc75 and the transection of the bowel then could be completed without any issues.No patient consequences were reported.

• Brand Name: N/A
• 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: 25270432
• Report Number: 3005075853-2026-03856
• Device Sequence Number: 9369545
• Product Code: GDW
• UDI-Device Identifier: 10705036002628
• UDI-Public: (01)10705036002628(17)300331(10)564D69
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 05/25/2026

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: 564D69
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2026
• Initial Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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