MEGADYNE MEGA SOFT Reusable Patient Return Electrode

Versatile and easy-to-use patient return electrodes designed for a wide variety of electrosurgical procedures.1 Simply place MEGADYNE MEGA SOFT Reusable Patient Return Electrode on the operating table and cover with a sheet and draw sheet.

MEGA SOFT Hero

Features & Benefits

  • Mega Soft - Card 1

    Patient-Centric Design

    More than 75 million procedures with zero pad site burns.2-7,* No adhesives - eliminates adhesive-related injuries.8 Can be used with patient warming devices.9-11,¥ Radiolucent and latex free.12

  • Mega Soft - Card 2

    Environmentally Friendly

    Reduce cost and waste. Environmentally friendly - reusable up to 24 months.13-14,¥ MEGADYNE MEGA SOFT Patient Return Electrode reduces SKUs and ordering hassles.14-15,¥ 

  • Mega Soft - Card 3

    One Size Fits All

    One patient return electrode for all your patients.16-17,Ÿ

  • Mega Soft - Card 4

    Easy To Set Up

    Easy to set-up - no skin prep required.18 Compatible with most major brands of isolated electrosurgical generators.19-20,Ý The reusable MEGADYNE MEGA SOFT Patient Return Electrode can be simply set on the operating table and covered by a sheet. 

Product Resources

Resources

MEGADYNE MEGA SOFT EMEA
MEGA SOFT Technology Video
0:02:46
MEGA SOFT Universal Video
0:03:56
Cleaning the MEGA SOFT Universal Patient Return Electrode
0:00:37
Connecting MEGA SOFT to the Generator
0:00:45

Supporting Documentation

Product Support

MEGADYNE MEGA SOFT Brochure

MEGADYNE MEGA SOFT Positioning Guide

MEGADYNE MEGA SOFT Specification Sheet

MEGA SOFT™ Technology Infographic

References

1. C2476

2. Ethicon, Letter To Whom It May Concern July 15, 2016 Signed by Melissa Fischer, May 2018, Data on File. (C2681)

3. Ethicon, Sales and Procedure Data, May 2018, Data on File. (C2681)

4. Ethicon, Megadyne Medical Products Inc 11500 South State Street Draper, UT 04020 USA www.megadyne.com, May 2018, Data on File. (C2681)

5. Ethicon, Range of search: 1999 - March 2017, May 2018, Data on File. (C2681)

6. Ethicon, 3000150-01_A Safer than CQM rev3, May 2018, Data on File. (C2681)

7. Ethicon, 28 February 2018 To: File From: Research & Development Subject: Most Universal and Universal Dual Mega Soft (REF 0845 & 0846) approved claims shall also apply to MEGADYNE MEGA SOFT Universal Plus and MEGADYNE MEGA SOFT Universal Plus Dual (0847 & 0848) on similarity of design, May 2018, Data on File. (C2681)

8. Ethicon, 28 February 2018 To: File From: Research & Development Subject: Most Universal and Universal Dual Mega Soft (REF 0845 & 0846) approved claims shall also apply to MEGADYNE MEGA SOFT Universal Plus and MEGADYNE MEGA SOFT Universal Plus Dual (0847 & 0848) on similarity of design, April 2018, Data on File. (C2340)

9. Ethicon, Megadyne MEGA Soft Universal REF 0845 MEGA Soft Universal REF 0846 Pateint Return Electrode and Akton Polymer Indications for Use (IFU), April 2018, Data on File. (C2411)

10. Ethicon, MEMO From: Jill Scozen To: Melissa K. Fischer RN, MSN, CNOR May 11, 2017 Re: Warming Devices used with Mega Soft, April 2018, Data on File. (C2411) 

11. Ethicon, 28 February 2018 To: File From: Research & Development Subject: Most Universal and Universal Dual Mega Soft (REF 0845 & 0846) approved claims shall also apply to MEGADYNE MEGA SOFT Universal Plus and MEGADYNE MEGA SOFT Universal Plus Dual (0847 & 0848) on similarity of design, April 2018, Data on File. (C2411)

12. Ethicon, 28 February 2018 To: File From: Research & Development Subject: Most Universal and Universal Dual Mega Soft (REF 0845 & 0846) approved claims shall also apply to MEGADYNE MEGA SOFT Universal Plus and MEGADYNE MEGA SOFT Universal Plus Dual (0847 & 0848) on similarity of design, April 2018, Data on File. (C2343)

13. Ethicon, Internal Correspondence July 15, 2016 Written By: Melissa Fischer Subject: Explanation of "75 Million Procedures, 0 Pad Burns" Statement, April 2018, Data on File. (C2341)

14. Ethicon, 28 February 2018 To: File From: Research & Development Subject: Most Universal and Universal Dual Mega Soft (REF 0845 & 0846) approved claims shall also apply to MEGADYNE MEGA SOFT Universal Plus and MEGADYNE MEGA SOFT Universal Plus Dual (0847 & 0848) on similarity of design, April 2018, Data on File. (C2341)

15. Ethicon, Letter To Whom It May Concern July 15, 2016 Signed by Melissa Fischer, April 2018, Data on File. (C2381), (C2681)

16. Ethicon, Megadyne MEGA Soft Universal REF 0845 MEGA Soft Universal REF 0846 Pateint Return Electrode and Akton Polymer Indications for Use (IFU), April 2018, Data on File. (C2630) 

17. Ethicon, Universal Plus Equivalency Memo, April 2018, Data on File. (C2630) 

18. Ethicon, 28 February 2018 To: File From: Research & Development Subject: Most Universal and Universal Dual Mega Soft (REF 0845 & 0846) approved claims shall also apply to MEGADYNE MEGA SOFT Universal Plus and MEGADYNE MEGA SOFT Universal Plus Dual (0847 & 0848) on similarity of design, April 2018, Data on File. (C2362)

19. Ethicon, MEGA 2000 and ReCORDable Generator Compatibility and Adapter Requirements, April 2018, Data on File. (C2627)

20. Ethicon, 28 February 2018 To: File From: Research & Development Subject: Most Universal and Universal Dual Mega Soft (REF 0845 & 0846) approved claims shall also apply to MEGADYNE MEGA SOFT Universal Plus and MEGADYNE MEGA SOFT Universal Plus Dual (0847 & 0848) on similarity of design, April 2018, Data on File. (C2627)

ÝPer internal research.

¥Compared to traditional “sticky” patient return electrode.

¥Refer to MegaSoft and respective patient warming device IFUs.

ŸAs per the IFU the device is intended to be used as a 24 month reusable patient return electrode for patients from .35 kg (0.8lb) and up (no maximum restriction).

*April 2018, per internal research conducted by Ethicon. Pad site burn is defined as a burn that occurs between the pad and patient and does not include alternate site or chemical burns.  For a complete list of warning and precautions please refer to the Instructions for Use.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.