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	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a pancreaticoduodenectomy, the device could be used without issues at the first firing during the initial duodenal transection, but the firing knob became stiff and did not move at the second firing during the gastric body transection.The doctor tried to advance the knife several times, but it did not move and the knife did not reach the stomach body.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: 8/24/2026.D4 batch # 757d69.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 reload present.The reload was received with the proximal 3 driver up and the swing tab was noted to be broken, making the reload nonfunctional.In addition, the reload was also damaged in the reload shroud at the same side where the remaining portion of the swing tab is placed.The device was tested for functionality with a test reload and it fired, cut, and formed all the staples as intended.The staple line and cut line were complete and the staples meet the staple form release criteria.It is possible that the damage on the swing tab was due to the reload was not properly loaded into the device, causing the damage to the swing tab and not allowing the device to fire.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.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 757d69, and no non-conformances related to the reported complaint condition 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: 50407418
• Report Number: 3005075853-2026-07028
• Device Sequence Number: 21488204
• Product Code: GDW
• UDI-Device Identifier: 10705036002628
• UDI-Public: (01)10705036002628(17)301231(10)870D04
• 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): 08/24/2026

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: 870D04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2026
• 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