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

Catalog Number HARXX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Failure to Anastomose (1028); Hematoma (1884); Hemorrhage/Bleeding (1888); Vomiting (2144); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 5/25/2023.B3: publication year of 2022.D4: 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.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: staple line complications without reinforcement, with oversewing and with buttressing using oxidized regenerated cellulose in laparoscopic sleeve gastrectomy, randomized comparative study.Authors: osama taha, md, phd, samia saied, md, phd, mohamed shoeib, md, phd, mahmoud abdelaal, md, phd, mohamed abozeid, md, phd, and mohamed talaat, md citation cite: doi: 10.1089/bari.2021.0033.This study aims to compare the outcomes of no-reinforcement, staple line oversewing and staple line buttressing with orc in lsg.Between march 2017 and march 2019, 300 patients were included in this randomized study, which was carried out in the bariatric surgery.Patients were randomized into three groups: 100 patients underwent lsg without reinforcement, 100 patients underwent lsg with oversewing of the staple line, and 100 patients underwent lsg with staple line buttressing by using orc.In group a, the greater omentum was dissected by using the harmonic scalpel (ethicon endo- surgery).For group b patients, the operative procedure proceeded till completion of the gastric sleeve and then the staple line was reinforced by continuous oversewing using absorbable 3-0 (vicryl).For patients in group c, the operative technique was similar to that of group a patients with using orc (surgicel snow haemostat, ethicon, llc).The abdominal drain was applied and port site wounds were sutured by using monocryl 3-0.Reported complications included inta-op: staple line hematoma (n=11), leakage (n=3), sleeve twisting (n=1), port site bleeding(n=1).Post-op: prolonged vomiting (n=21), post-op bleeding (n=13), wound infection (n=8), gerd( n=12), post-op staple line leakage (n=1).In conclusion oversewing of the staple line during lsg is a nonexpensive and easy method to decrease the incidence and severity of postoperative bleeding.However, it is timeconsuming and associated with a higher incidence of staple line hematoma and postoperative vomiting.It should be performed by experienced surgeons to avoid complications.Using orc is effective in reducing staple line bleeding in lsg compared with the control group.Both staple line oversewing and orc have no relation with occurrence of postoperative gastric leakage.

Manufacturer Narrative

(b)(4).Date sent: 7/6/2023 h6 = health effect - clinical code.

• Brand Name: HARMONIC ACE 5MM SHEAR
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17003826
• MDR Text Key: 315992277
• Report Number: 3005075853-2023-03546
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Required Intervention