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 Hematoma (1884); Unspecified Infection (1930); Necrosis (1971); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/21/2020.Date of event: publication year of 2011.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: comparing scalpel, electrocautery and ultrasonic dissector effects: the impact on wound complications and pro-inflammatory cytokine levels in wound fluid from mastectomy patients.Author : kerim bora yilmaz, lutfi dogan1, handan nalbant2, melih akinci, niyazi karaman1, cihangir ozaslan1, hakan kulacoglu.Citation: j breast cancer 2011 march; 14(1): 58-63; doi: 10.4048/jbc.2011.14.1.58.This prospective randomized trial was designed to assess the impact of scalpel, electrocautery, and ultrasonic dissector usage on wound complications and tissue damage.Between jan2009 and may2010, 82 consecutive patients with breast cancer underwent modified radical mastectomy (mrm) using scalpel (n=27; age of 50.2±9.3 years; bmi of 27.9±0.88), electrocautery (n=26; age of 48.5±9.8 years; bmi of 28.1±0.75) or harmonic scalpel (n=29; age of 52.0±9.5 years; bmi of 27.1±0.86).In ultrasonic dissector group, harmonic scalpel (ultrasicion® harmonic scalpel, generator 300; ethicon endosurgery, cincinnati, usa) were used individually on each patient to create skin flaps and excise breast tissue with underlying pectoralis fascia.All vessels larger than 3 mm in diameter were sealed with ultrasonic dissector.Ultrasonic dissector was also used for interpectoral dissection and cutting the head of the pectoralis minor muscle.In ultrasonic dissector group, complications included seroma (n=34.4%), surgical site infection (n=6.8%), hematoma (n=3.4%), ecchymosis (n=17.2%), and necrosis (n=6.8%).Ultrasonic dissector was as efficient as electrocautery in terms of hemostasis and decreasing the operation time yet it is as harmless as scissor in terms of seroma formation.In short, ultrasonic dissector was advantageous compared to the other two devices.

• 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: 9613333
• MDR Text Key: 188684645
• Report Number: 3005075853-2020-00494
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other