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

Catalog Number LX107

Device Problems Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 4/17/2024 d4: batch # unk 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 this device? were the clips visualized endoscopically during the initial surgical procedure? were there any complications during the initial surgical procedure? were scissored clips observed during the initial operation? were clips falling out of the applier during the initial operation? if so, was the device replaced? how was the procedure completed? what loading technique was used?(pencil grip, scissor grip?) how old was the device that was used? was a blood transfusion needed? if so, how much blood was given? what was observed at the site upon reoperation? were malformed clips observed? were scissored clips observed? (please describe shape of clip) what is current patient status?" an analysis of the product could not be performed since a physical sample was not received for evaluation.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 Description

It was reported that during a cabg procedure that the clips are either scissoring or falling out of the applier before they can be applied.Post op of the procedure, patient developed a bleed which was noticed by their hemoglobin dropping.Patient was brought back to the or and clipped the bleeding vessel which had previously received a scissored clip.Patient doing fine.

Manufacturer Narrative

(b)(4).Date sent: 5/15/2024.Additional information was requested and the following was obtained: "dr.Is a long time user of these devices.The surgical tech is as well.Patient that their hemoglobin had dropped so went back in a clipped the mammary gland i believe.The patient is fine.".

• Type of Device: APPLIER, SURGICAL, CLIP
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19125237
• MDR Text Key: 340449233
• Report Number: 3005075853-2024-02984
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036012856
• UDI-Public: 10705036012856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LX107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention