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

Catalog Number	ATS45NK
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unk procedure, went to fire first time and unformed staples collected in the bottom.They reloaded and the same thing happened again.Then they aborted the procdeure with no patient impact.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/16/2025.D4: batch # unk.The device/photo upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the surgery performed? what was the color of the cartridge? what was the targeted tissue? was the firing sequence started but not completed? if yes did the device deliver any staples? if yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? was the firing sequence started but not completed? if yes: did the device deliver any staples? if yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? if yes, was there any issue with the cut line? was there any difficulty opening the device jaws? 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.
Additional Manufacturer Narrative
(b)(4).Date sent 10/17/2025.D4 batch #891a09.Corrected data d4: udi#.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 ats45nk device was received with no apparent damage with a 6r45b reload loaded in the device and a second reload (b) present.The reload was received fully fired and the cartridge deck had some marks.The reload (b) was received fully fired with damage and marks on the reload deck and drivers.The device was tested for functionality with a test reload and it fired without any difficulties.The staple line was complete, and the staples meet the staple form release criteria.The damage to the reload is consistent with the device being clamped over a hard object.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.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 891a09, and no non-conformances were identified.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 23067050
• Report Number: 3005075853-2025-07354
• Device Sequence Number: 9681058
• Product Code: GDW
• UDI-Device Identifier: 10705036001089
• UDI-Public: (01)10705036001089(17)270630(10)X95H7N
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ATS45NK
• Device Lot Number: X95H7N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown