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

Catalog Number ACEXXX

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

Patient Problems Ischemia (1942); Blood Loss (2597); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2007

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2007.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: comparison of graft survival in live donor nephrectomy: hand-assisted laparoscopic v open procedures.Author: kyu-sung lee, m.D., jeong hee hong, m.D., seong soo jeon, m.D., han yong choi, m.D., sung joo kim, m.D., 3 and sung won lee, m.D.Citation: journal of endourology, volume 21, number 8, august 2007 doi: 10.1089/end.2006.0463.The objective of this study is to investigate hand-assisted laparoscopic donor nephrectomy (haldn) in comparison with standard open donor nephrectomy (odn) in living donors with regards to perioperative results, complications, and graft survival.Two hundred patients (96 females and 104 males) underwent left-sided nephrectomy between january 2001 to july 2004 and were followed up for more than 1 year.Of the 200 patients, 115 patients (56 females and 59 males) with mean age (years) of 40.8 ± 10.3 underwent odn while 85 patients (40 females and 45 males) with mean age (years) of 37.0 ± 10.0 underwent haldn.For the haldn, the harmonic scalpel (ethicon endo-surgery, cincinnati, oh) was used in all procedures for dissection and coagulation.Metal clips (ethicon endo-surgery) were applied on the renal artery, and the artery was transected.A 35-mm endo-gia stapler (ethicon endo-surgery) was used for division of the renal vein.Postoperative complications in the haldn group consisted of ileus necessitating prolonged hospitalization, and bleeding necessitating two units of transfusion in one patient each.The mean warm ischemic time was longer by 40 seconds in the haldn group.The authors concluded that hand-assisted laparoscopic nephrectomy in living donors is safe and effective with results similar to those of open nephrectomy with regard to graft function.

• Brand Name: ULTRACISION HARMONIC ACE (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: 9494766
• MDR Text Key: 188581965
• Report Number: 3005075853-2019-24566
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K051036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention