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

Catalog Number	ER320
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery, after fired, could not open the jaw.Opened the jaw manually with big force.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent 9/11/2026.D4 batch #: a70028.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 er320 device was returned with a clip present in the jaws and no apparent damage to the external components.In addition, the opened packaging was returned along with the instrument.In an attempt to replicate the reported incident, the device was subjected to functional testing.During testing, the trigger could not be actuated due to a jammed condition.The device was subsequently disassembled to assess the condition of the internal components.Examination revealed that the trigger was bent, preventing clip advancement into the jaws.Additionally, fourteen (14) clips were found remaining within the clip track at the time of analysis.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 a70028 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: 50733641
• Report Number: 3005075853-2026-07474
• Device Sequence Number: 10662443
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: (01)10705036012580(17)310131(10)895D00
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/11/2026

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: 895D00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2026
• 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