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

Catalog Number	MSM20
Medical Device Problem Codes	Failure to Form Staple (2579); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when being used in breast cases by surgeon.He feels that the clip applier is "misfiring".He feels that the clips are not forming properly.There have been no patient injuries/problems, this is precautionary.No surgical delay or patient harm was reported.
Additional Manufacturer Narrative
(b)(4).Date sent 8/12/2026 d4 batch # unk b3: exact date is unk.Assumed first day of the month.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please provide more details about the device quality issue.Did device jam (not fire clips)? did device not feed clips (clips not advance fully into jaws)? did device drop or eject clips? was there any other issue noted with the clip firing (sideways feed clip, malformed clips, scissored clips, etc )? did the clip not hold on the vessel or tissue once placed? was the device on a vessel/artery when it would not open? if yes, how was the device removed? (cut off, forced open) if the device was cut off, was there any damage to the vessel/tissue?.

• 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: 50222281
• Report Number: 3005075853-2026-06559
• Device Sequence Number: 13371072
• Product Code: GDO
• UDI-Device Identifier: 10705036002505
• UDI-Public: (01)10705036002505(17)310331(10)981D45
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K820837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2026

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: MSM20
• Device Lot Number: Lot: 981D45 Batch: A70174
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 08/25/2026; 09/09/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 08/26/2026; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2026
• 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