Rectifying Electrode Pads: MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Retention

This recall pertains to modifications in the usage instructions for these devices but does not necessitate their removal from the market. The FDA has classified this recall as serious, noting that unsafe continued use without adhering to the revised guidelines could result in severe injury or even death.

Affected Product

Figure 1: Megadyne MEGA SOFT Patient Return Electrode

Figure 2: Megadyne MEGA 2000 Patient Return Electrode

• Product Names: Megadyne MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes
• Unique Device Identifiers (UDI)/Product Codes:
  • MEGADYNE MEGA 2000 Patient Return Electrode: 10614559100936/0800
  • MEGADYNE MEGA SOFT Reusable Patient Return Electrode: 10614559101797/0830
  • MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode: 10614559101872/0835
• Lot/Serial Numbers: All serial numbers

What to Do

• Avoid using MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes on patients under 12 years old, despite the existing MEGA SOFT and MEGA 2000 labels permitting use for any patient over 25 lbs.
• Carefully adhere to cleaning, placement, and setup protocols for MEGA SOFT and MEGA 2000 pads to minimize the risk of patient burns.

On June 17, 2024, Megadyne dispatched an Urgent Medical Device Correction letter to all impacted customers advising the following actions:

• Distribute this communication to all users of MEGA SOFT and MEGA 2000 pads.
• Ensure that users are informed of the intended use restricted to patients aged 12 and above.
• Display the notification prominently for staff reference.
• Inform any facilities that may have received the product.
• Confirm the receipt of this notice within three business days by filling out the attached Business Reply Form and returning it to Sedgwick via fax at 844-441-2732 or at Ethicon8367@sedgwick.com.

Reason for Correction

Megadyne is amending the instructions for MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes following incidents of patient burns reported, particularly involving children under 12 during procedures that employed these devices.

The implications of using the implicated products can lead to significant adverse health effects including third-degree burns, scarring, and the possibility of additional surgeries.

Fifteen such injuries have been documented, with no fatalities reported.

Device Use

MEGADYNE MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Reusable Patient Return Electrodes are employed during electrosurgery, a procedure that utilizes electrical currents to either incise or cauterize tissue or to manage bleeding. The system comprises an electrosurgical generator that produces electrical currents delivered to tissues via a pen-like instrument. A return electrode pad guarantees contact with the skin of a patient lying down, channeling current away from tissue back to the electrosurgical generator to evade excessive heating.

Contact Information

For inquiries regarding this recall within the U.S., customers should connect with the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).

• Additional FDA Resources:
  • Related Recall Classification Summaries
  • FDA Enforcement Reports
  • Medical Device Recall Database Entries

Additional Company Resources:

Unique Device Identifier (UDI)

The unique device identifier (UDI) is instrumental in distinguishing each medical device sold in the U.S., tracking it from the point of manufacture to its eventual use. This system enables more precise reporting, monitoring, and analysis of adverse events associated with these devices, facilitating quicker identification and resolution of potential issues.

Reporting a Problem

Healthcare professionals and consumers are encouraged to report any adverse reactions or quality issues encountered while using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.