MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS SYNERGY DISECTING HOOK; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number SNGHK

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

Patient Problems Necrosis (1971); Seroma (2069)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2013.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.

Event Description

Title: harmonic scalpel versus electrocautery dissection in modified radical mastectomy: a randomized controlled trial.Author/s: salma khan, fcps, shaista khan, frcs, tabish chawla, frcs, and ghulam murtaza, mrcs, fcps.Citation: ann surg oncol (2014) 21:808¿814; doi 10.1245/s10434-013-3369-8.The aim of this randomized controlled trial was to test the hypothesis that although the harmonic scalpel increased operative time, it resulted in less intraoperative blood loss, less postoperative pain, smaller drainage volume, shorter procedure duration, and fewer complications [e.G., necrosis, seroma, and surgical site infections (ssi)] than electrocautery after modified radical mastectomy (mrm) in women with unilateral breast cancer.From april 2010 to july 2011, a total of 150 patients were randomized to electrocautery group (n=75) or harmonic scalpel group (n=75, mean age: 50.5 years, mean bmi: 28.1).During procedure, the breast tissue was reflected off the pectoralis major muscle with electrocautery or a j-hook harmonic scalpel (ethicon) as per the randomization.Subpectoral dissection was then carried out, and the medial and lateral borders of the pectoralis minor muscle were defined.The pectoralis minor was transected with the help of electrocautery or the harmonic scalpel.Complaints included seroma (n=16) and flap necrosis (n=2).In conclusion, harmonic dissection significantly reduces postoperative discomfort and morbidity to the patient without increasing operating time.

• Brand Name: HS SYNERGY DISECTING HOOK
• 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: 9485177
• MDR Text Key: 188348718
• Report Number: 3005075853-2019-24480
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036002819
• UDI-Public: 10705036002819
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K012176
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SNGHK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other