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

Catalog Number HARXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fever (1858); Unspecified Infection (1930); Sepsis (2067); Unspecified Tissue Injury (4559)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2021.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, echelon stapler and/or harmonic shears 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: endoscopic transmural drainage tailored to quantity of necrotic debris versus laparoscopic transmural internal drainage for walled-off necrosis in acute pancreatitis: a randomized controlled trial.Authors: suryalok angadi a, 1, soumya jagannath mahapatra b, 1, rahul sethia b, anshuman elhence b, asuri krishna a, deepak gunjan b, om prakash prajapati a, subodh kumar a, virinder kumar bansal a, pramod kumar garg b.Citation: pancreatology (2021); 21:1291-1298.Https://doi.Org/10.1016/j.Pan.2021.06.006.The aim of this randomized controlled trial was to compare transperitoneal laparoscopic drainage with endoscopic drainage using either lumen apposing metal stents (lams) or plastic stents tailored to the amount of necrotic debris in walled-off necrosis (won).Between may 2016 to june 2018, a total of 40 patients with acute pancreatitis and symptomatic won were included in the study.These patients were randomized to either endoscopic (n=20; 17 male and 3 female) or laparoscopic drainage (n=20; 18 male and 2 female).The median age of the patients was 32 (16-60) years in the laparoscopic group and 36 (21-51) years in the endoscopic group.In the laparoscopic group, a trans-gastric trocar guided cystogastrostomy was made with the help of ultrasonic harmonic shears/monopolar hook using a stapler (echelon¿ 60 endopath, ethicon endo-surgery, cincinnati, usa).In the endoscopy group, two plastic stents were placed if the won contained <1/3rd necrotic debris and a lumen apposing metal stents (lams) was placed if it was >1/3rd.Reported complications include secondary infection (n=5) of which 2 responded to antibiotics, and (n=3) of these had fever and evidence of sepsis of which 2 patients needed endoscopic intervention with endoscopic lavage and 1 patient required endoscopic necrosectomy; and iatrogenic colonic injury (n=1) necessitating conversion to open surgery for repair and diversion ileostomy.In conclusion, laparoscopic drainage was not superior to endoscopic transmural drainage with placement of multiple plastic stent or lams depending on the amount of necrotic debris for symptomatic won in ap.The hospital stay was shorter with the endoscopic approach.

• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15698271
• MDR Text Key: 302690726
• Report Number: 3005075853-2022-07371
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• 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: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention