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

Catalog Number HARXX

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

Patient Problems Dysphagia/ Odynophagia (1815); Fever (1858); Pyrosis/Heartburn (1883); Pain (1994); Vomiting (2144); Distress (2329); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2016.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.What is the specific number of patients who utilized harmonic scalpel and experienced transient dysphagia, gerd symptoms remission, midgastric stenosis, vomiting and gastric leak? does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.

Event Description

Title: simple versus reinforced cruroplasty in patients submitted to concomitant laparoscopic sleeve gastrectomy: prospective evaluation in a bariatric center of excellence.Authors: sara ruscio, mohamed abdelgawad, danilo badiali, olga iorio, mario rizzello, giuseppe cavallaro, carola severi, gianfranco silecchia.Citation: surg endosc (2016) 30:2374¿2381.Doi 10.1007/s00464-015-4487-0.The aim of this prospective study was to evaluate the safety and effectiveness of the reinforced cruroplasty during laparoscopic sleeve gastrectomy (lsg) compared with a concurrent group of simple cruroplasty.This prospective study involves 96 patients (78 females and 18 males; mean age 43.46 ± 11.1 years, mean bmi 43.55 ± 6.49 kg/m2) who underwent simultaneous lsg as a definitive procedure and cruroplasty from january 2012 to december 2014.The patient were divided into 2 groups: in group a, 48 patients (11 male and 37 female; age: 43.17 ± 10.41 years; mean bmi: 43.85 ± 6.05 kg/m2) with hiatal defect <4 cm2 with normal pillars underwent simple posterior cruroplasty and in group b, 48 patients (8 male and 40 female; age : 44.33 ± 11.6 years; mean bmi: 42.56 ± 9 kg/m2) with hiatal defect >4 and <8 cm2 with weakness of the right pillar underwent on-lay mesh-reinforced cruroplasty.The procedure started by division of the gastric greater curvature vascular supply starting 6 cm from the pylorus and proceeding proximally to the angle of his.Ultrasound dissection (harmonic scalpel, ethicon) was used.The hiatal defect was repaired with two or three interrupted nonabsorbable sutures from the right side (2¿0 polypropylene sutures, ethicon).Lsg was done using a linear stapler (echelon flex endopath, ethicon).Reported complications in group a included transient dysphagia (n-5) which resolved within 6 weeks by diet counseling and prokinetic drugs, gastroesophageal reflux disease (gerd) symptoms remission (n-14), midgastric stenosis (n-1) which was treated by endoscopic dilatation.Reported complications in group b included transient dysphagia (n-7) which resolved within 6 weeks by diet counseling and prokinetic drugs, gerd symptoms remission (n-19), fever and vomiting (n-1), and gastric leak (n-1) which was treated conservatively by self expandable metal stent (sems) placed endoscopically in fourth operative day and removed 14 days later.During the follow up visit, reported complications in group a included recurrent/persistent gerd (n-6) in which the patients with clinical and radiological recurrence were offered laparoscopic roux-en-y gastric bypass (rygb) and all cases showed symptom remission and gave up ppi within 3 months after surgery, and in group b included persistent/de novo gerd (n-2).Other complications during the follow up visit included upper gi symptoms (n-?), incompetent cardia (n-7), and weak esophageal peristalsis (n-7), and: a (b)(6) year old male with epigastric pain syndrome, and postprandial distress syndrome.A (b)(6) year old female patient with epigastric pain syndrome, and postprandial distress syndrome.A (b)(6) year old female patient with postprandial distress syndrome.A (b)(6) year old female patient with postprandial distress syndrome.A (b)(6) year old female patient with epigastric pain syndrome, and postprandial distress syndrome.A (b)(6) year old female patient with postprandial distress syndrome.A (b)(6) year old female patient with epigastric pain syndrome, and postprandial distress syndrome.A (b)(6) year old male patient with postprandial distress syndrome.In conclusion, the synthetic absorbable mesh offers an effective option for crural repair during lsg with low recurrence rates at 19 months.The midterm results of this prospective comparative study evaluating two different technical options for cruroplasty carried out during laparoscopic sleeve gastrectomy suggest that the simultaneous procedures are safe and cruroplasty is effective in mild-to-moderate gerd control in the majority of the cases.

• Brand Name: HARMONIC ACE 5MM SHEAR
• 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: 9696096
• MDR Text Key: 192147452
• Report Number: 3005075853-2020-00951
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K120729
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention