MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 5MM SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARXX

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

Patient Problems Edema (1820); Hematoma (1884); Necrosis (1971); Seroma (2069)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2017.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: a comparative study of the use of harmonic scalpel versus unipolar cautery in modified radical mastectomy.Author : pallavi mittal , ashwani kumar, sunmeet kaur, paras kumar pandove, rachan lal singla, jagpal singh.Citation: niger j surg.2017;23:1, 20-25.This comparative study aimed to evaluate the advantage of the harmonic scalpel in modified radical mastectomy in comparison with the traditional use of electrocautery (diathermy) for intraoperative and postoperative outcomes.A total of 50 female patients with confirmed diagnosis of breast carcinoma and planned for modified radical mastectomy were enrolled into two groups by random selection (the first group (group a) (n=25 females) who underwent modified radical mastectomy using harmonic scalpel (ethicon) and the second group (group b) (n=25 females, mean age: 50.36 years) underwent modified radical mastectomy using conventional electrocautery (unipolar cautery).In group a, the harmonic scalpel was used to raise skin flaps and carry out dissection of the breast tissue defined by the pectoralis major muscle below the clavicle superiorly, margin of the sternum medially, inframammary fold overlying the rectus abdominis inferiorly, and serratus anterior muscle to the latissimus dorsi muscle laterally.The instrument was also used to perform axillary dissection.Complaints included seroma (n=3), hematoma (n=1), wound infection (n=6), flap necrosis (n=2), and lymphedema (n=1).Patients with seroma formation settled down by multiple aspirations, with pressure bandage or open drainage within 1 month.The patients with flap necrosis and wound infections were treated with antiseptic dressings, systemic and local antibiotics, and debridement.The patients with wound infection were treated with antibiotics according to culture and sensitivity reports and with sterilized daily dressing.In conclusion, ultracision in comparison to electrocautery is somewhat but not fully advantageous and miraculous.No doubt it causes effective hemostasis and lymphostasis, but its use in modified radical mastectomy is still not cost effective and so, not recommended to be used in countries where cost is a major concern.

• Brand Name: HARMONIC ACE 5MM SHEAR
• 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 00969 ; 6107428552
• MDR Report Key: 9528397
• MDR Text Key: 189086103
• Report Number: 3005075853-2019-24778
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K120729
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other