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

Catalog Number LCSXX

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

(b)(4) batch # unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

Title : advanced hemostasis in axillary lymph node dissection for locally advanced.Breast cancer: new technology devices compared in the prevention of seroma formation.Author : claudio gambardella , guglielmoclarizia, renatopatrone, chiaraoffi, claudiomauriello1, robertoromano, marco filardo, alessandraconzo, alessandrosanguinetti2, andreapolistena2, nicolaavenia2 and giovanniconzo.Citation: gambardella et al.Bmc surgery 2019, 18(suppl 1):125; doi: https://doi.Org/10.1186/s12893-018-0454-8.The aim of the study is to compare the different haemostasis devices used in breast surgery, investigating the eventual superiority of an instrument among the others in terms of intraoperative and postoperative outcome,especially of seroma formation.Between jan2013 and jul2017, 100 consecutive female patients underwent axillary lymph node dissection for breast cancer and were retrospectively assigned into four groups accoding to device utilized during surgery: electrocautery (n=25), harmonic scalpel (n=25), ligasure (n=25), and thunderbeat (n=25).All procedures were performed by the same equip experienced in breast surgery according to standardized surgical technique.In harmonic scalpel group, postoperative complications included seroma (n=6) and n=lymphedema (n=2).Nowadays definitive etiology and pathophysiology of seroma formation are still unknown, despite different hypothesis were expressed, such as acute inflammatory reaction following surgical trauma, response to increased fibrinolytic activity in serum and lymph, reduction of fibrinogen levels in plasma.Patient¿s high body mass index, hypertension, preopera- tive radiation, tumor size, extended breast surgery, extended axillary lymph node involvement and theuse of electrocautery have all been related to seroma formation.In patients affected by breast cancer requiring axillary lymph nodes dissection, the use of advanced hemostasis devices is highly desirable.

• 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
• 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: 9345059
• MDR Text Key: 171981787
• Report Number: 3005075853-2019-23597
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: GEI
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• 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
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other