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

Catalog Number	EL5ML
Medical Device Problem Codes	Failure to Fire (2610); Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the device does not work.Does not fit into the 5mm trocar.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/22/2026.D4 batch # a99v8l.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 received with no apparent damage to the external components.In an attempt to replicate the reported incident, the device underwent functional testing.During evaluation, it was observed that clips failed to advance into the jaws upon subsequent trigger actuations.To further assess the condition of the internal components, the device was disassembled.Upon disassembly, the feed link was found to be broken, which disrupted the clip advancement mechanism and resulted in the observed feeding issue.Additionally, fourteen (14) clips were identified within the clip track.The broken feed link is considered the likely cause of the reported failure to feed clips into the jaws.The event reported was confirmed and it is related to improper use of the device.Possible causes for the damage found is due to the jaws may have been restricted during firing, or not fully through the trocar during firing.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 a99v8l number, and no non-conformances were identified.Additional information was requested, and the following was obtained: how did device not work? did device jammed (not fire clips)? did device not feed clips? did device drop or eject clips? did device sideways feed clips? did device fire malformed clips? did device fire scissored clips? if other please specify.I did not get a response from the surgeon.No further information available.

• 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: 50852973
• Report Number: 3005075853-2026-07838
• Device Sequence Number: 15958989
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• 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: A99V8L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2026
• 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