MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number EL5ML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Date 09/01/2023

Event Type  Injury  

Event Description

It was reported via journal article: title: an evaluation of titanium versus polymer clips in laparoscopic cholecystectomy.Author: (b)(6), do; john miller, md; colston edgerton, md; william hope, md.Citation: surg endosc (2023) 37:s345¿s564/https://doi.Org/10.1007/s00464-023-10072-3.A retrospective review of adult patients who have undergone standard laparoscopic cholecystectomy with or without intraoperative cholangiography by a single surgeon at novant new hanover regional medical center between november and april 2022.Fifty stratified consecutive cases utilizing titanium clips (ligamax 5mm clips), followed by 50 stratified consecutive cases utilizing competitor polymer clips (hem-olok, manufacturer: weck) were evaluated for the following primary outcomes: incidence of bile leaks, postoperative bleeding, need for additional procedures, and hospital length of stay.Reported complications are bile leak (n=1) and unspecified additional procedure (n=1).In conclusion, laparoscopic cholecystectomies performed with polymer clips have comparable clinical outcomes to those performed with titanium clips, while decreasing operative cost.

Manufacturer Narrative

(b)(4).Date sent: 10/3/2023.B3: unknown, assumed first day of month that complaint was reported.D4: batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.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.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17860725
• MDR Text Key: 324798009
• Report Number: 3005075853-2023-07116
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention