MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL GENERIC PRODUCT CODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSEALXXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Title: liver resections in children: tips, tricks and overcoming the initial learning curve.Authors: peters n., samujh r., malik m., yaddanapudi s., saxena a.Citation cite: pediatric blood and cancer.2020 dec.Retrospectively evaluated the data of consecutive 9 patients who underwent plr over a period of 21/2 years (january 2017 to june 2019).All patients underwent ultrasound abdomen, triple phase cect abdomen and ct scan chest.Average age was 19 months.Parenchymal resection was carried out using harmonic scalpel (ethicon) and enseal (ethicon) in all cases.Reported complications included post-operative bile leak (n=1), one patient succumbed on table with suspected air embolism.In conclusion plr is a technically challenging surgery.An exhaustive pre-operative work up, meticulous intraoperative steps and dynamic interaction with anaesthesiologists and radiologists and advanced energy sources aid in safe resections.Negative margins are achievable in most situations.

Manufacturer Narrative

(b)(4).Date of event: publication year of 2020.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 there were any ethicon device deficiencies that caused or contributed to the patient complications and/or the patient deaths? would the author/surgeon be interested in speaking with ethicon medical and engineering team regarding this event? 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.

• Brand Name: ENSEAL GENERIC PRODUCT CODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15490372
• MDR Text Key: 300653167
• Report Number: 3005075853-2022-06434
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention