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

Catalog Number	MCS20
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 4/3/2026 d4: batch # a9975d.Investigation summary the product was returned to ees for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual inspection of the returned mcs20 showed a clip in the jaws; the device exhibited no visible external damage.Two (2) tyvek (859d75, 863d39) were returned with the instrument.During functional testing the device was cycled and it successfully fed and formed the remaining nine (9) 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 performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Ensure that a clip is in the jaws.Position the jaws so that the clip completely surrounds the vessel to be ligated.Fully squeeze the handles together until they stop.As the handles are squeezed, the clip closes and occludes the vessel or tubular structure.Fully release the handles to return the instrument to its original open position.The next clip is automatically advanced.Inspect the jaws after each clip application to ensure the presence of a new clip before applying the next clip.Repeat steps as necessary to continue ligation of tissue.For optimal performance, periodically clean the instrument during the procedure by submerging the jaw and distal end of the applier shaft in saline.Device history review a manufacturing record evaluation was performed for the finished device batch a9975d number, and no non-conformances were identified.Additional information was requested and the following was obtained: 1.Could you please clarify if extra device belongs to this complaint? yes, this device belongs to this complaint.2.If not, could you please clarify if the extra received product belongs to a different complaint? if so, can you please provide the complaint number.N/a 3.If the device was not reported before, please provide more details of device malfunction.The device did not fire a clip.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.1.Were the jaws damaged? there appears to be damage on one of the jaws.I believe it was the mcm30 device.2.Was the device difficult to fire? no 3.Difficult to open? no 4.Does the device fired any malformed clips? yes, two of the devices caused clips to scissor.5.Does the device would not fire? no 6.If other please specify n/a.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 the plastic procedure there were three clip appliers were used.One clip applier didn't fire, and the other two clip appliers the ends came together so no clip could come out.No patient consequences.

• 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: 24783868
• Report Number: 3005075853-2026-02514
• Device Sequence Number: 6134500
• Product Code: GDO
• UDI-Device Identifier: 10705036002499
• UDI-Public: (01)10705036002499(17)301130(10)859D75
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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: 859D75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2025
• 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