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

Catalog Number	LX107
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 11/19/2024.D4: batch # unk.Additional information was requested and the following was obtained: "through this email, i allow myself to notify a serious adverse event reported to invima under the code: col241120165, possibly related to the medical devices detailed below: 2309fqga14429046 (01) 10705036012856 2309fqga14448067 (01) 10705036012894 case description: on the afternoon of october 8, the patient was admitted to myocardial revascularization surgery.Within the characteristics and techniques of this procedure, the grafts extracted for the realization of the coronary bridges are stapled, for this, two types of ligaclip ligation systems of two different brands were used: * teleflex - blue: (r.Invima: 2021dm-0007749-r1.Lot: 73e2400032) - amarillo: (r.Invima: 2021dm-0007749-r1.Lot: 73e2400028) * johnson - r.Invima: 2015dm-000771-r3 /804c41.Lote: 104d91 y 804c41 these were disclamped, causing a critical situation in the patient in the immediate postoperative period, who enters cardiocirculatory arrest, massive bleeding is identified through the mediastinal tube, which has to be reoperated urgently, hemopericardium of approximately 800 cc is identified.Bleeding from saphenous graft to the right coronary artery was identified.After the notification of the event, a review of the equipment involved was carried out, identifying a slight misalignment in the applicator of the johnson & johnson brand clips, which could be associated with the wear and tear of the sterilization process to which it has been subjected.As a preventive measure, the element was left in quarantine immediately.Conclusions of the analysis compared to the instrumental: the lx107 and lx207 clamps, used with the lt100 and lt200 reference ligaclips, could have generated an adverse event due to material wear, possibly related to the sterilization process and frequency of use.During visual inspection, a slight misalignment was observed at the tip of the tweezers." attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "what is the surgeons experience with the device? what is the current patient status? were there any issues with the device during the initial procedure? were there any issues with clip formations during the initial procedure? if yes, what was done to address the issue? please provide the product code of the ethicon devices and cartridges used with them what was observed at the site during reoperation? were malformed or scissored clips observed? will the devices be returning for analysis? have the devices been removed from circulation?" 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.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 unknown procedure, device has asymmetrical jaws and the clips are not formed properly.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/15/2025.The device 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: 2/12/2025.D4: batch # unknown.Investigation summary.The product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were 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 as stated in the ifu: 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.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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20725331
• Report Number: 3005075853-2024-08779
• Device Sequence Number: 8922661
• Product Code: GDO
• UDI-Device Identifier: 10705036012856
• UDI-Public: 10705036012856
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 01/15/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/15/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2023
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown