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#: unk.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.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: 24783202
• Report Number: 3005075853-2026-02513
• Device Sequence Number: 6132953
• Product Code: GDO
• UDI-Device Identifier: 10705036002499
• UDI-Public: (01)10705036002499(10)86D39
• 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: 86D39
• Was Device Available for Evaluation?: No
• 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): No
• 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