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	06/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 9/28/2026.D4 batch # z7050n.Investigation summary: the product was returned to lab cincinnati 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 received with the jaws closed and no apparent external damage.The device underwent ct scanning to evaluate its internal components, the trigger was found bent.To evaluate the reported incident, the device was subjected to functional testing.During testing, the device couldn¿t be fired as the trigger is bent.Furthermore, twenty-one (21) clips were found remaining within the clip track.As part of ethicon¿s 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 z7050n 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: 50788406
• Report Number: 3005075853-2026-07583
• Device Sequence Number: 10571365
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: (01)10705036012580(17)301130(10)842D76
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K812291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial,Followup

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: 842D76
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/09/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2025
• 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