MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL GENERIC PRODUCT CODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSEALXXX

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

Patient Problem Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that during review of journal article, title: comparative analysis between a bipolar vessel sealing and cutting device and the tie and suture technique in thyroidectomy: a randomized clinical trial.Author(s): k.Veronica chavez, md, e.Manuel barajas, md, jaqueline ram irez, md, juan pablo pantoja, md, mauricio sierra, md, david velazquez-fernandez, md, ms, phd, and miguel f.Herrera, md, phd, citation: surgery 2017;161:477-84; doi: http://dx.Doi.Org/10.1016/j.Surg.2016.07.036.This randomized controlled trial aimed to compare operative times, as well as other secondary outcomes, in thyroidectomies performed with either this advanced bipolar device (abd) or the tie and suture (t&s) technique.From may2014 to dec2015, 41 female patients underwent operative resection of a thyroid disease using either abd (n=21; mean age sd of 42.9 ± 12.1 years) or t&s (n=20; mean age sd of 50.6 ± 9.6 years) technique.Patients in the abd group were operated with the enseal g2 curved tissue sealer with a 14-cm shaft and the ethicon endo- surgery generator (gen11; ethicon).Regardless of vessel diameter, the inferior, middle and superior thyroid vessels were ligated with knot tying in the t&s group or were sealed with abd in the other group.Postoperative outcomes in abd group included transient decrease in >50% basal amplitude (7 nerves of 6 patients), vocal cord paralysis (n=1), symptomatic postop hypocalcemia (n=2) treated with either oral calcium or intravenous calcium infusion, transient hypoparathyroidism (n=2) and permanent hypoparathyroidism (n=1).The use of this abd in thyroid operation reduces significantly the operative time by 32 minutes compared with the t&s technique and has a similar safety profile.

• Brand Name: ENSEAL GENERIC PRODUCT CODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7878960
• MDR Text Key: 120380836
• Report Number: 3005075853-2018-12755
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K072177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other