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

Catalog Number	ER320
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgical procedure, the er320 clip applicator, lot 583d61, presented a functional failure at the time of use, since it did not trigger any clip.The event was identified during the procedure and the product was withdrawn for evaluation.No harm to the patient was reported.Was there any harm to the reported patient or user? no.Was there a significant delay? no.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/14/2026.D4 batch # z70515.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 er320 device was returned with a clip in jaws.The clip was removed in order to inspect the jaws and they were found with no damage.In an attempt to replicate the reported incident, the device was tested for functionality; however, the trigger could not be actuated due to a jammed condition.Upon inspection, both the upper and lower forks of the feeder plate were found lodged within the track.The adjacent areas of the track were intact and showed no evidence of damage, deformation, wear, or other abnormalities.The device was subsequently disassembled to evaluate the condition of the internal components.Internal examination revealed that the trigger was bent, preventing proper advancement of the clips into the jaws.Additionally, twelve (12) clips were found remaining within the clip track at the time of disassembly.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device batch z70515 number, and no non-conformances were identified.

• Brand Name: LIGACLIP
• 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: 50752459
• Report Number: 3005075853-2026-07490
• Device Sequence Number: 18451944
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: (01)10705036012580(17)300430(10)583D61
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K812291
• 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: ER320
• Device Lot Number: 583D61
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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