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

Catalog Number	ER420
Medical Device Problem Codes	Failure to Form Staple (2579); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/30/2026 d4: batch # z70259 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 er420 device revealed the presence of a clip within the jaws.The clip was removed to allow further evaluation of the jaws, which were found to be misaligned.In an attempt to replicate the reported incident, the device was tested for functionality.During evaluation, the instrument was cycled and successfully fed and formed four (4) scissored clips as a result of the jaw misalignment.The instrument subsequently locked out as intended.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.The event reported was confirmed and it is related to improper use of the device.Possible causes for the condition found may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.The reported complaint was confirmed.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Device history review a manufacturing record evaluation was performed for the finished device batch z70259 number, and no non-conformances were identified.Additional information was requested and the following was obtained: was there any other issue noted with the staple line other than bleeding (malformed clip, clip would not hold, etc.)? no, only malformed clips how was the bleeding controlled? with another clip applicator er420 how much blood was lost (ml)? 10 ml did the patient require a transfusion? no is the current patient status known? okay was there any patient consequence or change in the post-operative care of the patient as a result of the event? no.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 laparoscopic sigmoidectomy operation, bleeding occurred which was to be stopped using a clip applicator.However, some clips failed to close properly during application, necessitating the use of a new instrument to finish the procedure.No patient consequences were reported.

• 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: 24736778
• Report Number: 3005075853-2026-02378
• Device Sequence Number: 9214743
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: (01)10705036012597(17)300531(10)Z7025A
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K864102
• 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
• 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: ER420
• Device Lot Number: Z7025A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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