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

Catalog Number LCSXX

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

Patient Problems Seroma (2069); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/4/2019.Batch # unk.Date of event: year of publication 2006.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

Title : ultracision reduces acute blood loss but not seroma formation after mastectomy and axillary dissection: a pilot study.Author : a.Adwani, s.R.Ebbs.Citation: int j clin pract, may 2006, 60, 5, 562¿564 / doi : 10.1111 / j.1368-5031.2005.00689.X.The purpose of this pilot study was to determine if ultracision would reduce complications of intraoperative blood loss and seroma formation.A total of 42 patients with a histological diagnosis of breast cancer undergoing mastectomy and level 2 axillary clearance were included in the study.The patients were divided into 2 groups: ultracision group, [n=13, mean age 63 years (range 46-91 years)] patients underwent operation using harmonic scalpel (ultracision, ethicon); and control group, [n=29, mean age 67 years (range 42-89 years)] patients in which harmonic scalpel was unavailable.In ultracision group, the harmonic scalpel was used for the entire procedure with the exception of larger vessels which were ligated with 2/0 vicryl (ethicon).Postoperative complications included acute blood loss (n=?) and seroma formation (n=?).Acute blood loss was significantly reduced in the harmonic scalpel group in comparison with the control group.However, there was little difference between the two groups in terms of hospital stay, volume or duration of postoperative drainage or subsequent aspiration of seroma.

• 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: 9413771
• MDR Text Key: 187610261
• Report Number: 3005075853-2019-23980
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention