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

Catalog Number UNK_ULTRACISION HARMONIC FOCUS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dysphagia/ Odynophagia (1815); Nerve Damage (1979); Neurological Deficit/Dysfunction (1982); Respiratory Distress (2045); Burn, Thermal (2530)

Event Type  Injury  

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.

Event Description

Title: bilateral hypoglossal nerve damage due to the use of the harmonic focus scalpel.Author: radcliffe k, akhtar s, wilson a.Citation: bmj case rep.2020 jan 26;13(1); doi: 10.1136/bcr-2019-231573.This case report aims to highlight the need for proper training and specific identification of the hypoglossal nerve to prevent the rare and debilitating complication occurring in future patients.A (b)(6) year old man who presented with an anterior floor of mouth squamous cell carcinoma underwent bilateral neck dissection using harmonic focus scalpel (ethicon).The patient subsequently developed permanent bilateral hypoglossal nerve damage, causing significant dysphagia, dysarthria and breathing difficulties.This injury may have been caused by incorrect use of the harmonic focus scalpel.In conclusion, this case demonstrate that the harmonic focus scalpel causes more lateral thermal damage than alternative tools, and the widely accepted 3 mm safety limit is not enough to protect important surrounding structures.

• Brand Name: UNK_ULTRACISION HARMONIC FOCUS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9771512
• MDR Text Key: 192722343
• Report Number: 3005075853-2020-01341
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• 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: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other