You are about to leave jnjmedicaldevices.com. By clicking to continue, you will be taken to a web site governed by their own Legal and Privacy Policies.
Partner with ETHICON Energy, to build a stronger OR Safety environment by reducing the risks of:
Surgical Smoke
Exposure to surgical smoke can cause both acute and chronic health effects1*
Sharps Injuries
17% of sharps injuries in OR attributed to scalpel blades.2
Burns
There are between 2 to 5 reported electrosurgery injuries per 1000 patients.3
Education for Safety Awareness
Potential Dangers of Surgical Smoke
CDC*: “Exposure to surgical smoke can cause both acute and chronic health effects ranging from eye, nose and throat irritation to emphysema, asthma or chronic bronchitis1*
Burden and Epidemiology of Surgical Smoke Evacuation Value Analysis Brief
There are between 2 to 5 reported electrosurgery injuries per 1000 patients.3
29% of energy-based device complications reported to the FDA were pad-site burns.4≤
Energy Products Designed with OR Safety in Mind
The MEGADYNE portfolio offers a full range of electrosurgical products, including smoke evacuation systems, surgical pencils and blades, electrosurgical devices and capital equipment. Enhance patient protection with electrosurgery products to help you reduce the risks of burns.21
MEGADYNE MEGA SOFT Reusable Patient Return Electrodes
MEGADYNE MEGA SOFT Reusable Patient Return Electrodes
MEGADYNE Reusable Patient Return Electrodes have been used in more than 100 million procedures worldwide.5
MEGADYNE Telescoping Smoke Evacuation Soft Tissue Dissector
MEGADYNE Telescoping Smoke Evacuation Soft Tissue Dissector
Powered by GEM Technology. Less thermal damage§ and a flexible working length6-9§β, with smoke evacuation
ENDOPATH XCEL Trocars with OPTIVIEW Technology
ENDOPATH XCEL Trocars with OPTIVIEW Technology
Trocar sleeves for the 12 mm devices contain two seals, an outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 mm to 12 mm in diameter where indicated and an internal seal.17
MEGADYNE Electrosurgical Generator
MEGADYNE Electrosurgical Generator
The ETHICON MEGADYNE Electrosurgical Generator is designed to provide a simple user experience.10-13
MEGADYNE Smoke Evacuators
MEGADYNE Smoke Evacuators
Change the Air. Minimize exposure to surgical smoke in the operating room.18,19 The MEGADYNE Smoke Evacuator delivers effective and quiet performance for open and laparoscopic procedures.14-16¥
Trocars may help advance OR Safety
Our trocars help advance OR safety and decrease the risks of sharps injuries20
SAGES COVID-19 Announcements, Surgical Guidance and Smoke Evacuation
Ethicon shares your desire for a safe environment for your physicians, nurses, and all hospital staff. Ethicon supports SAGES’ position regarding the use of a smoke evacuator* in laparoscopic and open cases, in addition to the strict use of appropriate PPE.
* SAGES’ recommendation is general to smoke evacuators and is not specific to any one brand.
References
*Centers for Disease Control and Prevention
†In a preclinical porcine model at 60W vs. uncoated stainless steel blades at 60W (p<0.001).
‡May provide more efficient smoke evacuation by capturing smoke at the source.
§In a preclinical study of porcine abdominal tissue that utilized a blinded surgeon cosmetic assessment of thermal damage vs. PTFE-coated monopolar electrosurgery (p=0.031)
βThe legacy ACE Blade™ electrode and MEGADYNE™ Telescoping Smoke Evacuation Soft Tissue Dissector are one contiguous unit and are not sold separately. To achieve optimal device performance the MEGADYNE™ Telescoping Smoke Evacuation Soft Tissue Dissector should be used in combination with a Megadyne™ Generator in ACE/GEM mode
¥Efficiently captures and filters 99.999% of particulates and microorganisms of 0.1 to 0.2 microns and performs quiet at 50 +/- 10 dBa per IEC 60601-1 at 1 m, with 59.2 dBA in open mode and 51.9 dBA in lap mode at 1 m
≤Based on device-related complications reported to the FDA from January 1994 to December 2013
1. NIOSH Study Finds Healthcare Workers’ Exposure to Surgical Smoke Still Common. Nov 3, 2015. (132927-200819)
2. Jagger J, Berguer R, Phillips EK, Parker G, Gomaa AE, Increase in Sharps Injuries in Surgical Settings Versus Nonsurgical Settings After Passage of National Needlestick Legislation, American Journal of Surgery. 2011;93;322
3. Bae. H, Lee. M, Park. Ji, U. Intraoperative burn from a grounding pad of electrosurgical device during breast surgery A CARE-compliant case report, Medicine. 2018;97;1
4. Overbey DM, Townsend NT, Chapman BC, et al. Surgical Energy-Based Device Injuries and Fatalities Reported to the Food and Drug Administration. Journal of the American College of Surgeons. 2015;221:197-205
5. Ethicon, 07082019, MegaSoft Sales and Procedures Calculation 2019, Aug 2019, Data on File (117766-190702)
6. Ethicon, PSP005780A, Megadyne ACE Blade Thermal Damage Claims, Oct 2017, Data on File (157484-201029)
7. Ethicon, 14012019, Design Claims Memo for Telescoping Pencils, Jan 2019, Data on File (157484-201029)
8. Ethicon, 5800140-01, Extension Tube, Megadyne Telescoping Pencil, Sept 2019, Data on File (157484-201029
9. Ethicon, 6010145-01, Nozzle/Collet Assy., Megadyne Telescoping Pencil, Sept 2019, Data on File (157484-201029)
10. Ethicon Megadyne Electrosurgical Generator (MEGEN1) Technical Design Memo, February 2020, Data on File (132829-200218)
11. Summative usability and design validation protocol, June 2019, Data on File (132829-200218)
12. Golden Gate Marketing Claims Memo, June 2019, Data on File (132829-200218)
13. GEM Technical Monograph, October 2017, Data on File (132829-200218)
14. As per Instructions For Use (131252-200127)
15. Ethicon, ENG-RPT-704 Filter Physical characteristics comparison with predicate device filter, Oct 2019, Data on File (131252-200127)
16. Ethicon, ENG-RPT-753, MESE1 competitive sound test report, Feb 2020, Data on File (131252-200127)
17. Ethicon, 50060617, ENDOPATH XCEL® Trocar Instrument Compatibility Memo, Feb 2021, Data on File
18. AORN, periOperative Standards and Recommended Practices, AORN Inc. 2019; 1-24
19. As Per Instructions For Use
20. La Chapelle CF, Bemelman WA, Bongers MY, Van Barneveld TA et al, A multidisciplinary evidence-based guideline for minimally invasive surgery: part 2—laparoscopic port instruments, trocar site closure, and electrosurgical techniques, Gynecol Surg. 2013;10:11–23
21. Ethicon, 09/769,025, A capacitive reusable electrosurgical return electrode pad for use with electrosurgery, Jan 2001, Data on File