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 Cellulitis (1768); Unspecified Infection (1930); Necrosis (1971); Paralysis (1997); Seroma (2069)

Event Date 09/27/2021

Event Type  Injury  

Event Description

Title: introducing minimally invasive inguinal lymph node dissection in a uk tertiary skin cancer service: initial experience & outcomes.Authors: yeliz cemal , vivekanandan kumar , marc moncrieffa.Citation cite: journal of plastic, reconstructive & aesthetic surgery 75 (2022) 737¿742 https://doi.Org/10.1016/j.Bjps.2021.09.054.The aim of this study was to describe the outcomes of set- ting up an milnd service in a uk cancer centre inside a pre- scribed clinical governance framework.This was a retrospective, single-centre, single-surgeon cohort study.Twenty-one patients who underwent milnd from may 2015 to february 2019 were included.Demographic data, disease burden, and surgical quality assurance parameters were analysed.Median age was 69 (iqr: 58¿76) with 14 women (66%) and 7 men (33%).Dissection was performed with a harmonic scalpel (harmonic ace®, johnson & johnson, new jersey, usa) from caudal to cranial.The decision to ligate and resect the long saphenous vein distally and at the sapheno-femoral junction was made intraoperatively by the resecting sur- geon based on disease burden and location.Wherever pos- sible, the specimen was resected en bloc as a single packet.The cavity was subsequently irrigated with sterile water and two 15 french blake drains (ethicon, inc., new jersey, usa) were inserted into the cavity prior to port-site wound clo- sure.Reported complications included infection (n=4), seroma (n=1), skin necrosis (n=1, femoral nerve palsy, cellulitis in conclusion we report the first uk series of milnd in a cutaneous oncology service.Our re- sults show that milnd is a safe technique that can be introduced into a busy nhs practice with a structured training program, with surgical quality assurance outcomes identical to open inguinal lymphadenectomy.Our learning curve was similar to previously published data.

Manufacturer Narrative

(b)(4).Date sent: 9/12/2022.Batch # unk.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.Additional information was requested, and the following was obtained: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.Answer = there is no complaint to answer here.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: 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15402336
• MDR Text Key: 299693104
• Report Number: 3005075853-2022-05962
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention