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.Citation: surg endosc (2010) 24:2908¿2912; doi 10.1007/s00464-010-1041-y.(b)(4).

Event Description

It was reported via journal article: "title: intracorporeal circular-stapled esophagojejunostomy using hand-sewn purse-string suture after laparoscopic total gastrectomy".Author(s): takahiro kinoshita ¿ takashi oshiro ¿ katsuhiko ito ¿ hidehito shibasaki ¿ shinichi okazumi ¿ ryoji katoh.Citation: surg endosc (2010) 24:2908¿2912; doi 10.1007/s00464-010-1041-y.This study aimed to assess whether a circular-stapled anastomosis using hand-sewn purse-string suture is feasible for laparoscopic total gastrectomy (ltg).From sep2008 to may2009, 10 patients (n=9 male and n=1 female; median age of 63.7 years [range 45-80 years]) with gastric cancer underwent ltg.In all cases, esophagojejunal anastomosis was performed using ecs 25-mm circular stapler.Endoloop was apply to reinforce the ligation.Postoperatively, only one patient experienced intra-abdominal abscess which was treated conservatively with antibiotics.Esophagojejunostomy can be performed as in conventional open surgery.Hand-sewn purse-string suturing is demanding technically, but it can be performed safely by experienced laparoscopic surgeons.This technique is feasible and can lower the cost of the laparoscopic procedure.

• 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: 8204668
• MDR Text Key: 131698943
• Report Number: 2210968-2018-78086
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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: 12/07/2018
• 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