MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP; CLIP, IMPLANTABLE

Catalog Number	ER420
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/4/2026.B3: exact event date unk, entered 1/1/2026 as only the year was provided.D4: batch # y7048c.Investigation summary- the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the er420 device was received with a clip present in the jaws and no apparent external damage.The clip was removed to allow for inspection of the jaws, which were found to have no damage.Additionally, the opened packaging was returned along with the instrument.The device was then functionally tested in an attempt to replicate the reported incident.During evaluation, the device was cycled and successfully fed, retained, and formed the remaining ten (10) clips as intended.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.Device history review- a manufacturing record evaluation was performed for the finished device batch y7048c number, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that, during laparoscopic cholecystectomy, when a clip was applied, it was not properly deployed, and scissoring occurred at the tip.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: LIGACLIP
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 25400088
• Report Number: 3005075853-2026-04289
• Device Sequence Number: 10736778
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: (01)10705036012597(17)290831(10)Z7022L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: ER420
• Device Lot Number: Z7022L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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