MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC 5MM LAP SHEARS; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number LCS5HA

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

Patient Problems Injury (2348); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2005.Batch # unk.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: laparoscopic lymphadenectomy for gynecologic malignancies using ultrasonically activated shears: analysis of first 100 cases.Authors: farr nezhat, jyoti yadav, jamal rahaman, herbert gretz iii, ginger j.Gardner, carmel j.Cohen.Citation: gynecologic oncology 97 (2005) 813¿819.Doi:10.1016/j.Ygyno.2005.02.005.The objective of this study was to evaluate the safety and efficacy of the use of ultrasonic shears in performing laparoscopic lymphadenectomy in a larger cohort of patients at a single institution.This prospective study involves 100 patients (median age: 58 years; age range: 17-87 years) who underwent laparoscopic lymphadenectomy between january 1999 and april 2004.Ultrasonic shears (lcs5, ethicon) was used as the instrument for dissection and hemostasis.Reported complications included significant blood loss (n-?), injury to a branch of the inferior mesenteric artery (n-?) which was controlled with bipolar forceps, and injury to the right hypogastric vein during laparoscopic pelvic lymphadenectomy (n-?) which was managed with hemostatic clips.This is the largest series to date demonstrating the safety and efficacy of ultrasonic shears in laparoscopic lymphadenectomy for gynecologic malignancies.

• Brand Name: HARMONIC 5MM LAP SHEARS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9674033
• MDR Text Key: 191319109
• Report Number: 3005075853-2020-00781
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LCS5HA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other