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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Blood Loss (2597); 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.Citation: journal of laparoendoscopic & advanced surgical techniques.2009; 19(3).Doi: 10.1089/lap.2008.0368.(b)(4).

Event Description

It was reported via journal article "title : comparison of the electrothermal vessel-sealing system versus endoclip in laparoscopic appendectomy".Author: fatih aydogan, md, kaya saribeyoglu, md, osman simsek, md, ziya salihoglu, md, sinan carkman, md, tamer salihoglu, md, adem karatas, md, bilgi baca, md, ozan kucuk, md, nihat yavuz, md,and salih pekmezci, md.Citation: journal of laparoendoscopic & advanced surgical techniques.2009; 19(3).Doi: 10.1089/lap.2008.0368.Various techniques have been used for the division of mesoappendix.In the present study, ligasure and an endoclip were compared in laparoscopic appendectomy (la).This study included 280 patients who underwent la for acute appendicitis at (b)(6) between may 2003 and april 2007.The patients were assigned to two groups according to the mesoappendix dissection device: ligasure (127 patients; 71 male and 56 female patients; age: 31.49 ± 13.99) and endoclip (153 patients; 83 male and 70 female patients; age: 30.92 ± 14.1) groups.During the surgical procedure, the appendix was identified and freed from inflammatory adhesions.The mesoappendix was divided by using ligasure or ligaclip endoclip (ethicon).The appendix was ligated and divided with an endoloop (ethicon) at its base.In the endoclip group, reported complications included uncontrollable mesoappendix bleeding, associated with ligaclip endoclip application (n-2) which was converted to an open procedure and inappropriate endoloop closure (n-1).In this study, the comparison of two groups revealed that the use of the ligasure was associated with a shorter operating time and less conversion rate than ligaclip endoclip application in la.The ligasure seems to be a safe, useful tool for mesoappendix dissection.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: CANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY
• 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: 7856385
• MDR Text Key: 119643773
• Report Number: 2210968-2018-75709
• 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,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2018
• 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