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 Unspecified Infection (1930); Sepsis (2067)

Event Date 08/15/2021

Event Type  Injury  

Event Description

Title: early to midterm survival of patients with deep sternal wound infection managed with laparoscopically harvested omentum.Authors: mohamed marzouk, richard baillot, dimitris kalavrouziotis, nawal amhis, joseph nader, frederic s hould, laurent biertho, siamak mohammadi, tarek malas.Citation cite: j card surg.2021;36:4083¿4089.Doi: 10.1111/jocs.15955.The objective of this study was to evaluate outcomes of patients with dswi managed with transposition of laparoscopically harvested omentum (lho).Between 2000 and 2020, a total of 38,623 adult patients who underwent full median sternotomy for cardiac surgery were analyzed retrospectively at our institution.Dswi occurred in 455 (1.2%), of whom 364 (93.2%) were managed with pectoralis myocutaneous flap (pmf) and 33 (7.2%) with lho.Ultrasound scissors with bipolar coagulation (ethicon, endo-surgery inc.) were used.In all patients, two silastic drains (blake drain; ethicon, inc., a johnson & johnson company) were placed in the subcutaneous and pectoralis dissection planes.Reported complications included reinfection postgrafting with laparoscopically harvested omentum (lho) (n=1), septicemia (n=5).In conclusion use of lho is a safe and viable alternative to traditional myocutaneous flaps to manage complex dswi.Early and late survival were favorable in this highrisk population.

Manufacturer Narrative

(b)(4).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 caused or contributed to the patient complications mentioned in the article? if yes, please explain.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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13157006
• MDR Text Key: 287345743
• Report Number: 3005075853-2022-00012
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• 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
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention