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

Catalog Number	LT400
Medical Device Problem Codes	No Apparent Adverse Event (3189); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 12/4/2025 d4: batch # 645d64.Investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample revealed that 13 lt400 cartridge were received sterile with no apparent damage and along with two tyveks.The cartridges were opened and tested for functionality with a test device; a drop test was performed on the cartridges and no loose clips were noted.Upon functional testing of the clips, the instrument loaded, retained, and deployed 6 clips per sample as intended.The clips were from as intended and conforming to our manufacturing requirements.The event described could not be confirmed as the clips performed without any difficulties noted and no loose clips were noted.Device history review a manufacturing record evaluation was performed for the finished device lot 645d64, and no non-conformances were identified.Additional information was requested and the following was obtained: she said she didn¿t have any more details.Was there any other issue noted with the staple line other than bleeding (malformed clip, scissoring clips, clip would not hold, etc.)? the clips were sharp how was the bleeding controlled? unknown.How much blood was lost (ml)? unknown.Did the patient require a transfusion? unknown.Is the current patient status known? unknown.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? unknown.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 a vascular procedure, cutting the vessel resulted in bleeding instead of clamping.No further information provided.No patient consequences were reported.

• 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: 23716076
• Report Number: 3005075853-2025-09184
• Device Sequence Number: 8910457
• Product Code: FZP
• UDI-Device Identifier: 10705036012832
• UDI-Public: (01)10705036012832(17)300531(10)645D64
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K830503
• 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): 12/04/2025

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: LT400
• Device Lot Number: 645D64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown