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

Catalog Number UNK_ULTRACISION HARMONIC FOCUS

Device Problem Patient Device Interaction Problem (4001)

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

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.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.

Event Description

Title: ultrasonic dissection versus electrocautery for immediate prosthetic breast reconstruction.Author(s): dongeun lee, bok ki jung, tai suk roh, young seok kim.Citation: arch plast surg 2020;47:20-25; this retrospective study aimed to compare the effects of using an ultrasonic dissection device or a monopolar electrosurgical device during prosthesis-based breast reconstruction on seroma formation and short-term postoperative complications.Between mar2017 and sep2018, 122 breasts underwent total mastectomy and immediate reconstruction with a prosthesis.From march 2017 to january 2018, patients underwent surgery with a monopolar electrosurgical device (group 1; n=58; mean age of 47.6±7.0 years; mean bmi of 23.3±2.8 kg/m^2) and from february 2018 to september 2018, an ultrasonic dissection device was used (group 2; n=64; mean age of 45.1±6.8 years; mean bmi of 22.4±2.8 kg/m^2).In group 2, we performed hemostasis in the whole surgical field using an ultrasonic dissection device (harmonic focus; ethicon, cincinnati, oh, usa).The origin of the pectoralis major muscle was dissected and elevated using the instrument.After the muscle was adequately elevated, we made a slit incision on a piece of acellular dermal matrix (adm), which had been immersed in an antibiotic solution, and fixed the adm in the new inframammary fold location using vicryl 3-0 sutures.The pocket was closed by suturing the adm and the pectoralis major muscle.After subcutaneous suturing, subdermal suturing was performed using the buried technique, and skin closure was performed using 5-0 nylon sutures.The other surgical methods were the same in both groups, except for the dissection device.Postoperative complications included seroma (n=18 group 2); hematoma (n=5 group 2); surgical site infection (n=2 group 1 and n=3 group 2); and flap necrosis (n=5 group 1 and n=4 group 2).Currently, the leading causes of seroma formation are thought to be persistent inflammation after mastectomy, thermal damage to tissue, and lymphatic disruption.In this study, the use of an ultrasonic dissection device decreased the seroma formation rate.It seems that when elevating the pectoralis major muscle, there was less thermal damage of the anterior chest wall and muscle, which reduced the formation of seroma due to inflammation.In conclusion, the rate of seroma formation can be slightly reduced by using an ultrasonic dissection device for immediate implant-based breast reconstruction.

• 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: 10593790
• MDR Text Key: 209748786
• Report Number: 3005075853-2020-04949
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• 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: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other