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	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the clip is stuck.Have there been reports of injuries from patients or users? no.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/22/2026.D4 batch # a98v1t.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 el5ml device was received with no apparent damage.In addition, the tyvek packaging was returned along with the instrument.In an attempt to replicate the reported incident, the device underwent functional testing.During evaluation, the instrument was cycled; however, during subsequent actuations, the clips failed to advance into the jaws.To further assess the condition of the internal components, the device was disassembled.Upon disassembly, the feeder shoe tab was found to be damaged, which interfered with the clip advancement mechanism and resulted in the observed feeding issue.Additionally, ten (10) clips were identified within the clip track.Based on these findings, the damaged feeder shoe tab is considered the likely cause of the reported failure to feed clips into the jaws.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached regarding what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device batch a98v1t 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: 50853024
• Report Number: 3005075853-2026-07839
• Device Sequence Number: 9936582
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: A98V1T
• 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: 09/18/2025
• 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