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 Problem Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 11/19/2019.Batch # unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Additional information requested but unavailable: what was the number of patients who developed seroma in harmonic scalpel group?.

Event Description

Title : axillary lymphadenectomy for breast cancer in elderly patients and fibrin glue author : giovanni docimo*, paolo limongelli1, giovanni conzo, simona gili, alfonso bosco, antonia rizzuto, vincenzo amoroso, salvatore marsico, nicola leone, antonio esposito, chiara vitiello, landino fei, domenico parmeggiani, ludovico docimo.Citation: docimo et al.Bmc surgery 2013, 13(suppl 2):s8; doi: http://www.Biomedcentral.Com/1471-2482/13/s2/s8.This prospective study evaluates the effectiveness of using fibrin glue to reduce seroma formation following axillary lymphadenectomy for breast cancer.Between jan2010 and dec2012, 30 patients (over 60 years) with n+ breast adenocarcinoma underwent either quadrantectomy or modified radical mastectomy with level i/ii axillary lymphadenectomy.The axillary lymphadenectomy was performed in 15 patients with ligations, scissors and electrocautery and in 15 patients with ultrasound scalpel.The harmonic scalpel group received the suction drain without additional treatment, while the other group received fibrin glue (tisseal®/tissucol®, baxter healthcare corporation, (b)(4) usa).Seroma magnitude and duration were not significant in patients receiving fibrin glue compared with the harmonic scalpel group.Fewer evacuative punctures were reported in harmonic scalpel group (n=3).Use of fibrin glue does not always prevent seroma formation, but can reduce seroma magnitude, duration and necessary evacuative punctures.

• 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: 9345082
• MDR Text Key: 185015527
• Report Number: 3005075853-2019-23598
• 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: 10/21/2019

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: No Information
• Device Catalogue Number: LCSXX
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other