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 Death (1802); Hematoma (1884); Necrosis (1971); Sepsis (2067)

Event Type  Death  

Manufacturer Narrative

(b)(4).Date sent: 11/26/2019.Date of event: publication year of 2015.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.(b)(4).

Event Description

Title: impact of the surgical experience on leak rate after laparoscopic sleeve gastrectomy, author(s): patrick noel & marius nedelcu & michel gagner citation: obes surg (2016) 26:1782¿1787 / doi 10.1007/s11695-015-2003-1.The purpose of this retrospective study was to analyze the correlation between the surgeon¿s experience and the leak rate after lsg.Between sep 2005 and dec 2014, a total of 2012 lsg cases were performed.The greater curvature of the stomach was freed, starting from the middle of the stomach, with a sealing device: the harmonic scalpel (ultracision, ethicon) for group a (n=1000) and the ultrasonic bipolar dissect or (thunderbeat) for group b (n=1012).Reinforcement by seromuscular suturing was not used for the first 1200 cases.In the last 800 cases, gore seamguard bioabsorbable staple line reinforcement was used.In all cases, hemostasis of the staple line was done by bipolar grasp, and in 378 patients, an additional vicryl 3.0 stitch was used between the staple lines.Postoperative complications included hematoma (n=22, n=20 group a, n=2 group b), stenosis (n=2), gastric leak (n=20, n=18 group a, n=2 group b), infarctus (n=1) and sepsis (n=1).Lsg can be performed with a low complication rate.This large series of a single surgeon¿s experience demonstrated that the leak rate after lsg could be significantly decreased over time with changes in techniques.

• 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: 9378793
• MDR Text Key: 168098260
• Report Number: 3005075853-2019-23796
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051036
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: ACEXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• 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
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Death