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

Catalog Number UNK_ULTRACISION HARMONIC FOCUS

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problem Nerve Damage (1979)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Title: does the combined use of magnification loupes and harmonic focus improve the outcome of thyroid surgery authors: luca p suffat, eugenia lavorini, guido mondini, ivan lettini, giulia osella, lodovico rosato citation cite: world journal of endocrine surgery (2020): 10.5005/jp-journals-10002-1283 the aim of this study was to evaluate the impact of optical magnification (loupes) and ultrasound hemostatic devices, with the aim of highlighting any benefit in terms of surgical procedures, operating times, and outcome in thyroid surgery.A total of 140 patients undergoing total thyroidectomy for either diffuse or nodular goiter were enrolled between january 2016 and june 2019 at our endocrine surgery unit.A total of 70 patients operated with magnifying loupes and ultrasonic scalpel, defined as group a, were compared with other 70 patients operated without loupes and with the aid of conventional hemostatic devices, named as group b.In group a, harmonic focus(ethicon) was used for dissection and coagulation throughout the entire surgical procedure, except for the superior and inferior thyroid arteries and veins with diameter of =5 mm, which were ligated and dissected.In group b, surgical procedures were performed using the conventional clamp-and-tie technique.The ligatures were performed, always extracapsular, with vicryl 2/0 sutures(ethicon) for the main vascular pedicles and 3/0 for minor vessels, with the aid of bipolar coagulation.Reported complications included temporary single recurrent laryngeal nerve (rln) palsy occurred in only one patient and patients benefited from a 6 weeks program of logopedic rehabilitation.In conclusion use of magnification loupes and harmonic scalpel is associated with significant reduction of operating/anesthesia time and intraoperative blood loss.

Manufacturer Narrative

(b)(4).Date of event: 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 11/16/2021.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 they don't attribute the onset of complications to the use of focus, if used appropriately.

• Brand Name: UNK_ULTRACISION HARMONIC FOCUS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12706212
• MDR Text Key: 284361398
• Report Number: 3005075853-2021-06442
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ULTRACISION HARMONIC FOCUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention