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 the device did not fire intra op.No harm to patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/17/2026.D4 batch#: a7024x.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.To evaluate the reported incident, the device underwent functional testing.During testing, the instrument was fired; however, the clips failed to advance into the jaws.Additionally, upon subsequent trigger actuations, no clips were fed into the jaw assembly.The device was subsequently disassembled for detailed internal inspection.Upon disassembly, the feed link was found to be broken, and the advancer was observed to be bent.These conditions were determined to have caused the clip-feeding malfunction.Furthermore, fifteen (15) clips were recovered from within the clip track during the internal evaluation.The event reported was confirmed and it is related to improper use of the device.However, it is known from the history of the device that bent advancer condition may lead to malformed clips.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.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 ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch a7024x number, and no non-conformances were identified.

• 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: 50805658
• Report Number: 3005075853-2026-07655
• Device Sequence Number: 10581445
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: Batch: A7024X
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2026
• 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