MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; CANNULA, SURGICAL, GENERAL

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

Patient Problems Abscess (1690); Fever (1858); Post Operative Wound Infection (2446); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 number has not been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (endoloop vicryl suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (endoloop vicryl suture) used in this procedure? citation: journal of laparoendoscopic & advanced surgical techniques volume 27, number 6, 2017; doi: 10.1089/lap.2016.0433.(b)(4).

Event Description

It was reported via journal article: title: "a comparison of endoloop ligatures and nonabsorbable polymeric clips for the closure of the appendicular stump during laparoscopic appendectomy in children." author(s): zenon pogorelic´, md, phd, boris kostovski, md, ana jeron cic´, phd, tomislav susnjar, md, msc, ivana mrklic´, md, phd, miro jukic´, md, and ivo juric´, md, phd.Citation: journal of laparoendoscopic & advanced surgical techniques volume 27, number 6, 2017; doi: 10.1089/lap.2016.0433.This study aimed to identify the incidence of complications after the application of polymer ligating clips and compare them with endoloop ligatures.Between jun2011 and jun2016, 277 patients who underwent laparoscopic appendectomy because of suspected appendicitis and were allocated according to stump closure technique: polymer clips group (n=101; n=63 male and n=38 female; median age of 13 years) and endoloop group (n=176; n=84 male and n=92 female; median age of 13.5 years).In the procedure, the mesoappendix was dissected with either ultracision or ligasure.In endoloop group, vycril endoloop -0 was placed at the base of the appendix and the appendix was divided 5 mm above the loop with the device used for dissecting the mesoappendix.Postoperative complications in endoloop group included wound infection (n=2) which were managed conservatively, intra-abdominal abscess (n=3) treated with either reoperation or conservative management, and fever lasting >3 days (n=4) which were treated conservatively.The potential risk factor for the development of intraabdominal abscesses might be protuberant mucosa of the appendiceal stump, distal of the closing devise which was already been described for the endoloop system.Closure of the appendix stump with polymeric nonabsorbable clips in laparoscopic appendectomy reduces operative time and may be a cost-effective and simpler alternative to widely used endoloops.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: CANNULA, SURGICAL, GENERAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8197476
• MDR Text Key: 131434731
• Report Number: 2210968-2018-78036
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/26/2018
• 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