MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP; APPLIER, SURGICAL, CLIP

Catalog Number	LX107
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 2/10/2026 d4: batch # unk d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The device/photo upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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 an unk procedure, functional issues with all five clip appliers in the lot.Specifically, the lapra-ty devices did not seat properly on the jaws and would not close or lock as intended.In addition, both the hem-o-lock blue clip appliers and the white clip appliers were unable to hold the clips securely and were noted to be misaligned.No patient consequence were reported in association with these failures.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/4/2026.The device/photo upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/30/2026.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the lx107 device was returned nonfunctional as the jaws were damaged; therefore, the clips could not be loaded into the jaws.The event reported was confirmed and it is related to improper use of the device.Please note that all surgical instruments are subject to a degree of wear and tear because of normal use.A regular and precise visual check of the instrument should be made before each use.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Device history review: an evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

• Common Device Name: APPLIER, SURGICAL, CLIP
• 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: 24305396
• Report Number: 3005075853-2026-01211
• Device Sequence Number: 9660882
• Product Code: GDO
• UDI-Device Identifier: 20705036012853
• UDI-Public: 20705036012853
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 03/30/2026

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: LX107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 03/04/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/04/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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