MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 55MM SELECTABLE NEW TLC; STAPLE, IMPLANTABLE

Catalog Number	NTLC55
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent 3/24/2025 d4 batch #362c95 b3: only event year known: 2024.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 ntlc55 device was received with the anvil partially detached on the distal end and the anvil post on this area and one on the proximal end appears to be damaged as if the anvil was pulled out of the device.No reload was received.In addition, 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 condition of the anvil, is related 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.A manufacturing record evaluation was performed for the finished device batch number 362c95, and no non-conformances were identified.
Event or Problem Description
The device was received with no complaint information.Attempts were made to reconcile the device with no success resulting in the creation of a new complaint.Awb 282277633033 received 12/04/2024.Box marked as (b)(4) on awb 282277633033; recd ntlc55; lot# 362c95; ecm has ntlc75; lot# 508c77 from country india.

• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21676545
• Report Number: 3005075853-2025-02104
• Device Sequence Number: 7693691
• Product Code: GDW
• UDI-Device Identifier: 10705036002611
• UDI-Public: (01)10705036002611(17)280630(10)362C95
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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: 362C95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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