MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN); INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number ACEXXX

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

Patient Problems Nerve Damage (1979); Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2010.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: minimally invasive video-assisted thyroidectomy (mivat): what is the real advantage? author : paolo del rio & maria francesca arcuri & paola pisani & belinda de simone & mario sianesi.Citation: langenbecks arch surg (2010) 395:323¿326 doi 10.1007/s00423-009-0589-2.The objective of this study was to identify the differences between video-assisted and traditional thyroidectomies by compiling and comparing the authors¿ video-assisted results with respect to postoperative complications (hypocalcaemia, nerve palsy and postoperative bleeding) with the outcomes of patients receiving conventional thyroidectomy.Of the 1,015 patients who underwent total thyroidectomy from july 2005 to march 2009, 211 patients (4:1 female/male ratio) with a mean age of 50.6 years, underwent mivat.A total of 587 of the 804 patients who underwent total open thyroidectomy during the same period were matched with the mivat group.The procedure for mivat was performed in accordance with miccoli¿s technique.The section of the pedicle superior vessels was detached with the use of the ultracision cs 14 (ethicon endosurgery) and/or single use automatic clip applier s-90 (autosuture).To perform a total thyroidectomy, all the steps of the procedure were repeated in the contralateral thyroid.There were 6 cases of monolateral nerve palsy, and after 6 months, a definitive palsy in two cases.These two cases were treated.In two sufficient (aesthetic result) cases, a skin burn was observed.In conclusion, the authors reported that patients treated with mivat showed an improvement in incidence of postoperative hypocalcaemia, postoperative pain, postoperative stay, psychophysical recovery and cosmetic result.

• Brand Name: ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
• 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: 9655157
• MDR Text Key: 190131064
• Report Number: 3005075853-2020-00681
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K051036
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACEXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other