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

Catalog Number	MCS20
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the mcs20 disposable clip appliers, particularly in commando procedures within ent surgery, specialists experience recurring issues with clip formation.On average, at least three clips per device are reported to be malformed, resulting in inadequate closure, clip dislodgement, or bleeding.In addition, mechanical issues are frequently observed, including failure to fire or incomplete firing.The procedures were delayed by 15 minutes and completed successfully.
Additional Manufacturer Narrative
(b)(4) date sent: 5/23/2026 d4: batch # 897d56.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device batch number of 897d56 / 46mcs20 , and no non-conformances were identified.Additional information was requested and the following was obtained: 1.How was the bleeding controlled? 2.How much blood was lost (ml)? 3.Did the patient require a transfusion? 4.Was there a patient consequence? if yes, how was the issue addressed? questions 1 through 4 (removed), since this is a report regarding a single code concerning multiple problems with this clipper? that is also fully explained in the text.5.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event? no 6.Could you please clarify if the product issues that have occurred been reported to customer quality? no 7.If yes, do you have the complaint submission numbers (pc numbers)? n/a 8.What is the total number of procedures/patient events? approximately three patients per week since january, every clip applier has at least 3 malformed clips.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.

• Brand Name: LIGACLIP
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 25264579
• Report Number: 3005075853-2026-03833
• Device Sequence Number: 21174609
• Product Code: GDO
• UDI-Device Identifier: 10705036002499
• UDI-Public: (01)10705036002499(17)310131(10)897D56
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K820837
• 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,Followup
• Report Date (Section B): 06/16/2026

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: MCS20
• Device Lot Number: 897D56
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/23/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2026
• 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