MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number LCSXX

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

Patient Problems Edema (1820); Fistula (1862); Hematoma (1884); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event: publication year for the journal article is 2015.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

It was reported that during review of a journal article, title: lymphatic complications control following inguinal and axillary radical lymph node dissection: a randomized controlled trial.Author: matthey-gie m.-l; gie o; deretti s.; demartines n.; matter m.Citation: european journal of lymphology and related problems.Conference: 41st european society of lymphology congress, esl 2015.Switzerland.26 (72) (pp 18), 2015.This randomized controlled trial aimed to evaluate the efficacy of the harmonic scalpel for radical lymph node dissection (rlnd).Between 2009 and 2013, a total of 80 patients undergoing inguinal or axillary rlnd or completion lymph node dissection after positive sentinel lymph node biopsy (slnb) for melanoma or sarcoma were included in the study.The patients were randomly assigned in group hs (dissection was conducted with harmonic scalpel (ethicon)) (n=40) and group c (dissection was conducted by ligation and monopolar electrocautery).Complaint included lymphoedema (defined as an increased circumference of the operated limb of more than 10%) (n= 50%), lymphatic fistula (n=5%), lymphocoele (n=32.5%), and hematoma (n=5%).In conclusion, the use of harmonic scalpel failed to offer a significant reduction for length of drainage and operative complication, even an increased rate of lymphoedema was observed.Thus, traditional surgical management can be used safely in rlnd.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 9511369
• MDR Text Key: 177941246
• Report Number: 3005075853-2019-24737
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LCSXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other