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 Problem Abscess (1690)

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.To date no response has been provided.If further details are received at a 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 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 used in this procedure? citation: surg laparosc endosc percutan tech 2013; 23: 255¿258.(b)(4).

Event Description

It was reported via journal article: title: "a comparison of nonabsorbable polymeric clips and endoloop ligatures for the closure of the appendicular stump in laparoscopic appendectomy: a prospective, randomized study." authors: elif colak, md, metin kement, md, nuraydin ozlem, md, tahir mutlu, md, kadir yildirim, md, ahmet gurer, md,w and recep aktimur, md.Citation: surg laparosc endosc percutan tech 2013; 23: 255¿258.The aim of this prospective randomized trial was to evaluate the clinical outcomes of hem-o-lok ligation system in laparoscopic appendix stump closure by comparing the endoloop ligature.Between sep2010 and jul2011, 53 patients underwent laparoscopic appendectomy and were randomized into two study groups: group hem-o-lok (n=26; n=13 male and n=12 female; age of 31.9±13.2 years) and group endoloop (n=27; n=15 male and n=12 female; age of 26.8±11.7 years) for appendicular stump closure.In group endoloop, the base of the appendix was ligated using 2 proximal and 1 distal endoloop ligatures.Postoperatively in endoloop group, only one patient developed periappendicular abscess and was treated successfully by interventional drainage.The most significant postoperative complication was periappendicular abscess which developed in a single patient from the endoloop group.But, it is impossible to say whether it was caused by continuing local peritonitis or by leakage of the stump since the patient had perforated appendicitis.

• 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: 8200514
• MDR Text Key: 131544621
• Report Number: 2210968-2018-78054
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2018

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
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/27/2018
• 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