• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON ENDO-SURGERY, LLC. HS SYNERGY DISECTING HOOK; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9485177
MDR Text Key188348718
Report Number3005075853-2019-24480
Device Sequence Number1
Product Code LFL
UDI-Device Identifier10705036002819
UDI-Public10705036002819
Combination Product (y/n)N
Reporter Country CodePK
PMA/PMN Number
K012176
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Catalogue NumberSNGHK
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/21/2019
Initial Date FDA Received12/17/2019
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 Number1
Patient Outcome(s) Other;
-
-