MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number ACEXXX

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Hematoma (1884); Necrosis (1971); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event: publication year for the journal article is 2011.This report is related to a journal article; therefore, no product will be returned for analysis.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that during review of a journal article, title: ultrasonic shears in free-tissue transfer : increased efficiency and cost savings.Author(s): cody a.Koch, steven m.Olsen, eliot j.Martin and eric j.Moore.Citation: otolaryngology¿head and neck surgery 144(2) 201¿205 doi: 10.1177/0194599810391846.The objective of this prospective cohort study is to investigate the use of ultrasonic shears as a means to decrease operative time and increase surgical efficiency in the harvest of microvascular free flaps.There were 69 patients who underwent fibula free flap (fff) and 39 patients who underwent anterolateral thigh (alt) free flap reconstruction of head and neck defects conducted from october 1, 2005, through december 30, 2009.The patients were assigned either to the ultrasonic group (fff or alt) or to the no ultrasonic group (fff or alt).A total of 53 patients (18 females, 35 males), ages ranging from 8 - 81 years (mean age- 56 years), were assigned to the ultrasonic fff group and 16 patients (6 females, 10 males), ages ranging from 32 - 70 years (mean age- 54 years), were assigned to the no ultrasonic fff group.There were 26 patients (5 females, 21 males), ages ranging from 31 - 78 years (mean age- 63 years), who were assigned to the ultrasonic alt group and 13 patients (4 females, 9 males), ages ranging from 32 - 79 years (mean age- 54 years), who were assigned to the no ultrasonic alt group.The harvest of some microvascular free flaps and dissection of multiple perforating vessels and/or muscular attachment were performed using either the ultrasonic shears (harmonic scalpel, ethicon endosurgery, inc, cincinnati, ohio), the traditional clamp-cut-tie technique, or the ligaclip mca multiple clip appliers (ethicon endosurgery).The harmonic scalpel was used in the ultrasonic fff and alt groups and either the traditional or ligaclip was used in the no ultrasonic fff and alt groups.An average of 5 units of ligaclip appliers were used per procedure.The complications noted in the no ultrasonic fff group included 1 recipient site hematoma, 1 small wound dehiscence, and 1 recipient site abscess.The complications noted in the ultrasonic fff group included 3 recipient site hematomas, 2 cases of wound dehiscence, and 1 recipient site abscess.The average follow-up for patients in the no ultrasonic fff group was 24 months (1-46 months) and 15 months (1-32 months) for the ultrasonic fff group.There were no complications reported in the no ultrasonic alt group but there 4 complications noted in the ultrasonic alt group.The complications included 2 cases of partial wound dehiscence and 2 cases of distal partial flap necrosis, one of which required pectoralis major pedicled flap closure.The average follow-up for patients in the no ultrasonic alt group was 19 months (0-46 months) and months (2-36 months) for the ultrasonic alt group.In conclusion, the authors reported that the use of ultrasonic shears in the harvest of microvascular free flaps decreases operative time, leading to significantly decreased costs without an increased risk of complications compared to traditional dissection techniques.

Manufacturer Narrative

(b)(4).Date sent: 1/21/2020.Corrected data: h10: date sent is 1/21/2020, not 1/21/2019.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9613165
• MDR Text Key: 182538511
• Report Number: 3005075853-2020-00491
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACEXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Required Intervention