MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	NTLC55
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/23/2026.D4: batch # 533c16.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 a half of the height selector broken inside a plastic bag along with the right bearing and no reload was returned for analysis.Further analysis shows the anvil partially detached due to three anvil post of these area appears to be damaged as if the anvil was pulled out off the device.Also, the anvil shroud was noted to be broken where the shroud support the metal body causing the easy movement on this area, and this condition most likely caused the missing bearing and the staple height selector damaged.No functional test was performed due to the condition of the device.Based on the condition of damages observed in the device 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.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.Device history review a manufacturing record evaluation was performed for the finished device batch number 533c16, and no non-conformances related to the reported complaint condition 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 the while doing a colectomy procedure, new ntlc55 gun did not work.It was used for the first case.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: 24666168
• Report Number: 3005075853-2026-02181
• Device Sequence Number: 20097482
• Product Code: GDW
• UDI-Device Identifier: 10705036002611
• UDI-Public: (01)10705036002611(17)280630(10)533C16
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: NTLC55
• Device Lot Number: 533C16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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