MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS ARTIC LNR CUTR NO KNIFE; STAPLE, IMPLANTABLE

Catalog Number	ATS45NK
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 07/30/2025 d4: batch #891a08.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 revealed that the ats45nk device was received with no apparent damage and with no reload present.During the mechanical testing, it was noted that the firing mechanism on the device was damaged.However, the closing trigger worked and the device closed as expected.No further functional testing could be performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the firing trigger teeth were found broken.No conclusion could be reached as to what caused the firing mechanism to fail as no cartridge was returned for analysis.The event described could not be confirmed as the device closed without any difficulties noted.Although it could not be determine the cause of the reported incident, proper usage of the endo linear cutters - ets45mm is important to ensure functionality.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 #ats45nk, with lot/batch #x95x9k, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 891a08, 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 unknown procedure, the surgeon used ats45nk with tr45w.When he tried to pull the closing trigger, he was not able to.Then when he pulled it strongly, the closing trigger broke.There was no patient consequence nor surgical delay reported.No additional information provided.

• Brand Name: ETS ARTIC LNR CUTR NO KNIFE
• 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 00969 ; * 00969 ; 3035526892
• MDR Report Key: 22664531
• Report Number: 3005075853-2025-06010
• Device Sequence Number: 12624808
• Product Code: GDW
• UDI-Device Identifier: 10705036001089
• UDI-Public: (01)10705036001089(10)X95X9K(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K020779
• 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): 07/30/2025

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: ATS45NK
• Device Lot Number: X95X9K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TR45W
• Patient Sex: Unknown