MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH; STAPLE, IMPLANTABLE

Catalog Number	ATS45NK
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/16/2026 d4: batch #713a31.Additional information was requested, and the following was obtained: was the firing sequence started but not completed? if yes: >>yes did the device deliver any staples? >>yes if yes, were the staples formed properly? >>yes if yes, was the staple line complete?>>yes did the device cut?>>yes if yes, was the cut line complete? >>no.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 damaged and with a tr45w reload no loaded on the device.The returned reload was partially fired 1/2.In addition, a tyvek was received along with the sample.The device and a test reload were tested for functionality, it fired and formed the staples as intended.The staple line was complete, and the staples meet the staple form release criteria.It should be noted that endopath ets flex 45 no knife is not designed to cut.The condition of the reload indicates that the device's firing cycle was interrupted.When firing the device make sure that the firing stroke is completed.Do not partially fire the device.Fire the device by squeezing the firing trigger completely until it rests on the closing trigger.Once the firing cycle has been initiated, it must be completed.If the re-initiation of firing is resumed, the device will lockout.Firing through the lockout mechanism will break the device.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 #x94p0f, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 713a31, 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 unspecified surgical procedure, it was observed that the device was stuck and could not be used normally.There was no patient consequence nor surgical delay reported.No additional information provided.

• Brand Name: ENDOPATH
• 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: 24899298
• Report Number: 3005075853-2026-02927
• Device Sequence Number: 18344377
• Product Code: GDW
• UDI-Device Identifier: 10705036001089
• UDI-Public: (01)10705036001089(17)270228(10)X94P0F
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/16/2026

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: ATS45NK
• Device Lot Number: X94P0F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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
• Patient Sex: Unknown