MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. LIGAMAX; CLIP, IMPLANTABLE

Catalog Number	EL5ML
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure there was an issue with the device.There was no patient harm.
Additional Manufacturer Narrative
(b)(4) date sent 9/24/2026 d4 batch # a98w5w b3: only event year known: 2026.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 el5ml device was returned with no apparent damage, and the tyvek packaging was received with the instrument.To evaluate the reported event, the device was functionally tested.Upon firing the instrument, the clips did not advance into the jaws as intended.Inspection of the internal mechanism revealed a bent advancer tip.Following disassembly, the advancer deformation was confirmed, and six (6) clips were found remaining within the clip track.The observed advancer deformation is consistent with the failure of clip advancement during device operation.The event reported was confirmed and it is related to improper use of the device.Please note that prior to loading a clip in the jaws, ensure that the demarcation between the jaws and the device shaft is past the end of the trocar cannula.Additionally, excessively applying a side load to the jaws, causing them to partially collapse could result in a clip malformation.The device jaws should be fully open and parallel upon initiating the firing of the device.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch a98w5w number, and no non-conformances were identified.Additional information was requested, and the following was obtained: 1.Could you please provide the lot #/batch #? 2.Did device not feed clips (clips not advance fully into jaws)? 3.Did device drop or eject clips? 4.Did device sideways feed clips? 5.Did device fire malformed clips? 6.Did device fire scissored clips? 7.Did the clip not hold on the vessel or tissue once placed? i have no other information on this complaint other than they were able to change to a new device for all instances and continue with the operation, no patient harm.

• Brand Name: LIGAMAX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50883702
• Report Number: 3005075853-2026-07945
• Device Sequence Number: 10664246
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial

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: EL5ML
• Device Lot Number: A98W5W
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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