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	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the clip applier "jammed" during lap chole procedure.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Date sent 9/25/2026.D4 batch # a7000l.Investigation summary.The product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the el5ml device was returned with the distal tip of the shaft broken.In addition, the tyvek packaging was returned along with the instrument.In an attempt to replicate the reported incident, functional evaluation revealed that clips did not advance into the jaws upon the next trigger actuation.To assess the condition of the internal components, the device was disassembled.Internal examination identified a fractured feed link, which prevented proper clip advancement and was determined to be the cause of the feeding malfunction.Additionally, fifteen (15) clips were present within the clip track.No other anomalies or damage to the internal components were observed during the evaluation.Possible causes for the damage found may be inadvertent pressure placed on the device shaft through bending, pressing against the trocar, other devices on the back table, using the device as a retractor or moving heavy tissue with the device shaft.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 a7000l 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: 50896058
• Report Number: 3005075853-2026-07980
• Device Sequence Number: 10684668
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: (01)10705036001843(17)301231(10)A7000L
• 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: A7000L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2026
• 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