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

Catalog Number	ATS45
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/28/2026.D4: batch#: unk.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: please provide more details about the device quality issue.Did the device deliver any staples? if yes, were the staples formed properly? what was the appearance of the deployed staples (b-formed, malformed, goal post/legs straight)? were there staples missing from the staple line? 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? if yes, what steps were taken to open the jaws? if the jaws could not be opened, how was the device removed? was there a patient consequence? if yes, how was the issue addressed? could you please clarify if there were any change in the post-operative care of the patient as a result of the event? 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 ats45 device was received with the anvil opened, the knife exposed between the jaws and with no reload present.During the mechanical testing, it was noted that the firing mechanism of the device was damaged.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.The event reported was confirmed and it is related to improper use of the device.The damage found on the firing teeth of the device is consistent with the device experiencing an increase of the internal forces resulting in the component yielding as a result of firing through the device lockout mechanism.Firing through the lockout mechanism will break the device.It is possible that the device was attempted to fire through a locked reload in previous firings.It is likely that the previous cartridges used during the procedure and not returned for complaint evaluation would have exhibited damage to the cartridge lockout spring.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 ats45 with lot number: 602d97; and no non-conformance's were identified.A manufacturing record evaluation was performed for the finished device batch number 576d83, and no non-conformance's 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 a laparoscopic cholecystectomy procedure, it was observed that the device locked out.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: 25020752
• Report Number: 3005075853-2026-03192
• Device Sequence Number: 10399410
• Product Code: GDW
• UDI-Device Identifier: 10705036001072
• UDI-Public: (01)10705036001072(17)300430(10)602D97
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 04/28/2026

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: ATS45
• Device Lot Number: 602D97
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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