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 Failure to Anastomose (1028); Obstruction/Occlusion (2422); Blood Loss (2597)

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.Was the case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product 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 product used in this procedure? citation: surg endosc (2015) 29:3386¿3391, doi 10.1007/s00464-015-4073-5.(b)(4).

Event Description

It was reported via journal article "title : surgical outcomes of intracorporeal circular-stapled esophagojejunostomy using modified over-and-over suture technique in laparoscopic total gastrectomy".Author: takeru matsuda, takeshi iwasaki, masaaki mitsutsuji, kenro hirata, yoko maekawa, daisuke tsugawa, yutaka sugita, etsuji shimada, yoshihiro kakeji.Web address: doi 10.1007/s00464-015-4073-5.Esophagojejunostomy in laparoscopic total gastrectomy (ltg) is a technically demanding procedure.The authors developed a simple method for intracorporeal circular-stapled esophagojejunostomy using a modified over-and-over suture technique.The surgical outcomes of our technique were evaluated in comparison with those of open total gastrectomy (otg).From april 2012 to august 2014, reconstruction using this method in ltg was performed for 21 consecutive patients (14 male and 7 female; age range: 44 to 79 years old; bmi 19 to 31) with gastric cancer (ltg group).Their surgical outcomes were compared with those of 27 patients (22 male and 5 female patients; age range: 52 to 88 years old; bmi: 18 to 3) with gastric cancer who underwent otg without splenectomy (otg group) between january 2011 and april 2014.During the ltg procedure, a suture ligated in advance was tied once, and then, the position of the anvil head was adjusted and fixed in the proper position by additional ligation of the thread, which was reinforced using an endoloop ligature (ethicon).In the ltg group, reported complications included anastomotic leakage (n-1), anastomotic stenosis (n-1), bleeding (n-1), and intestinal obstruction (n-1).Ldg is currently a standard surgical option for treatment of gastric cancer worldwide, which is mainly because of successful standardization of the surgical techniques, including reconstruction and lymph node dissection.The authors considered that the method is safe and feasible for most laparoscopic surgeons with basic skills in laparoscopic suturing.Moreover, the surgical outcomes of this technique were comparable with those of otg.

• 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: 8197860
• MDR Text Key: 131496287
• Report Number: 2210968-2018-78040
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• 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: 12/05/2018
• 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