MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. UNK_ULTRACISION HARMONIC FOCUS; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number UNK_ULTRACISION HARMONIC FOCUS

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Nerve Damage (1979); Thyroid Problems (2102)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2020.Batch # unk.This report is related to a journal article, therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

Title: 'thyroidectomy with energy-based devices: surgical outcomes and complications comparison between harmonic focus, ligasure small jaw and thunder beat open fine jaw'.Author(s): gian luigi canu, fabio medas, francesco podda, alberto tatti, giuseppe pisano, enrico erdas, pietro giorgio calò.Citation: gland surg 2020;9(3):721-726; doi: 10.21037/gs.2020.03.31.The aim of this retrospective study was to compare harmonic focus (hf), ligasure small jaw (lsj) and thunder beat open fine jaw (tb) in terms of surgical outcomes and complications.Between jan2012 and jun2018, 1165 with benign (n=754) and malignant thyroid (n=411) underwent conventional open total thyroidectomies and were allocated into three treatment groups: using hf, group a (n=1012; n=287 male and n=725 female; mean sd age of 54.82±13.97 years); using lsj, group b (n=96; n=22 male and n=74 female; mean sd age of 55.09±13.85 years); and using tb, group c (n=57; n=16 male and n=41 female; mean age of 51.58±15.64 years).In group a, harmonic focus (hf; ethicon, johnson and johnson, cincinnati, oh, usa) was used in the thyroidectomy.The cervical linea alba and platysma were sutured with absorbable sutures and skin was closed by a continuous intradermal suture.Postoperative complications in group a included transient hypoparathyroidism (n=215), permanent hypoparathyroidism (n=63), cervical hematoma (n=19), unilateral recurrent laryngeal nerve injury (n=26), and bilateral recurrent laryngeal nerve injury (n=3).Hf, lsj and tb have proved to be safe and effective.The postoperative stay, and complications were comparable between the three groups.

Manufacturer Narrative

(b)(4).Date sent: 9/24/2020.H10: corrected data = h1.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Additional information was requested and the following was obtained: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.From the author: i think no.

• Brand Name: UNK_ULTRACISION HARMONIC FOCUS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10560014
• MDR Text Key: 214537050
• Report Number: 3005075853-2020-04767
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ULTRACISION HARMONIC FOCUS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Other