URGENT: FIELD SAFETY NOTICE

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Natalie Kelly
5 years ago
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[Date] Dear Operating Room Supervisors and Chief of Surgery: Our records indicate that you have ordered or received the Megadyne Mega Power Electrosurgical

PLEASE FOLLOW THE MEGADYNE MEGA POWER ELECTROSURGICAL GENERATOR MANUAL AND DO NOT PLUG TWO DEVICES INTO THE SAME PORT (CHANNEL) FOR THE PRODUCT LISTED BELOW.

issued a voluntary Field Safety Notice to request customers follow the Megadyne Mega Power Electrosurgical Generator manual and only plug one active device into

1 [Date] Dear Operating Room Supervisors and Chief of Surgery: Our records indicate that you have ordered or received the Megadyne Mega Power Electrosurgical Generator. PLEASE DISTRIBUTE THIS INFORMATION TO ALL PERSONNEL RESPONSIBLE FOR Megadyne Mega Power Electrosurgical Generator. PLEASE FOLLOW THE MEGADYNE MEGA POWER ELECTROSURGICAL GENERATOR MANUAL AND DO NOT PLUG TWO DEVICES INTO THE SAME PORT (CHANNEL) FOR THE PRODUCT LISTED BELOW. PRODUCT NAME Mega Power Electrosurgical Generator PRODUCT CODE Serial Numbers 1000 All DESCRIPTION / SIZE Capital Equipment Electrosurgical Generator Megadyne issued a voluntary Field Safety Notice to request customers follow the Megadyne Mega Power Electrosurgical Generator manual and only plug one active device into each channel at a time (See Figure 1). This notification affects all Megadyne Mega Power Electrosurgical Generators. Correct Correct Incorrect Figure 1. Correct and Incorrect Device Connections Page 1 of 7

A label (See Figure 2) has been supplied to your Biomedical Engineering Manager to apply to all Megadyne Mega Power Electrosurgical Generators in your facility.

2 A label (See Figure 2) has been supplied to your Biomedical Engineering Manager to apply to all Megadyne Mega Power Electrosurgical Generators in your facility. This label is to remind users to follow the user manual (reference ) and only plug one active device into each channel at a time (See Figure 1). When incorrectly plugging two active accessories into one channel, the generator powers both accessories when either of the two accessories are activated. It is possible that exposure to the second activated device may lead to a burn injury (up to second-degree) to the patient or operator if the second device is not in use and rested on top of the patient. Figure 2. Label Your Biomedical Engineering Manager has been provided with the following instructions to apply the label to each Megadyne Mega Power Electrosurgical Generators in your facility. INSTRUCTIONS FOR APPLYING THE LABEL 1. Ensure the front of the generator has been cleaned following instructions in the Megadyne Mega Power Electrosurgical Generator manual. 2. Remove the liner from the label. 3. Place the label on the generator according to Figure 3 (New Faceplate) or Figure 4 (Old Faceplate). For the New Faceplate please ensure the label is inside the green area just to the left of the MEGADYNE logo as shown in Figure 3 to ensure good adhesion. For the Old Faceplate please ensure the label is positioned between and below the Blend and Standard buttons as shown in Figure Please ensure that all Megadyne Mega Power generator users at your site have read this letter and ensure they understand the intent of the label which is: DO NOT have more than one device plugged into the same port at the same time. Page 2 of 7

post-operatively in the usual manner with no additional action required.

3 Figure 3. Label Placement (New Faceplate) Figure 4. Label Placement (Old Faceplate) This correction affects all s. Health care practitioners who have treated patients using the Megadyne Mega Power Electrosurgical Generator should follow those patients post-operatively in the usual manner with no additional action required. Refer to Attachment 1 for assistance in identifying the product subject to this correction. This medical device voluntary correction has been communicated to health authorities, including the U.S. Food and Drug Administration (FDA). Page 3 of 7

4 IDENTIFICATION OF THE PRODUCT SUBJECT TO THIS CORRECTION: The products subject to this correction in your inventory can be identified by product code. The product code (1000) can be determined by using the Product Identification Tool within Attachment 1. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have any Megadyne Mega Power Electrosurgical Generator(s) subject to this correction. 2. Communicate this issue to all relevant operating room, biomedical engineering, and anyone else in your facility who needs to be informed. If any of the devices subject to this correction have been forwarded to another facility, please contact that facility and forward this notification and enclosed label(s) to them. 3. Please ensure that all relevant operating room, biomedical engineering, and anyone else in your facility who needs to be informed have read the letter and ensure they understand the intent of the label which is: DO NOT plug more than one device into a port at the same time. 4. Confirm that the label supplied to the Biomedical Engineering Manager has been placed on the generator according to Figure 3 or Figure Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and it directly to your Mega Power distributor who sent you this notification within three (3) business days. Please return the BRF even if you do not have the product subject to this correction. 6. Keep this notice visibly posted for awareness for all Megadyne Mega Power Electrosurgical Generator users. At Megadyne, our first priority is to support the needs of our customers and their patients, and that includes the safe and effective use of our products. We recognize this is disruptive to your facility and we apologize for any inconvenience this may cause. If you have additional questions regarding this correction or to report any customer complaints, please contact your Mega Power generator distributor. Attachments: Attachment 1: Product Identification Tool Attachment 2: Business Reply Form Page 4 of 7

correction. All Megadyne Mega Power Electrosurgical Generators are subject to this correction.

5 ATTACHMENT 1: Product Identification Tool for Megadyne Mega Power Electrosurgical Generator. This tool will help customers identify the Megadyne Mega Power Electrosurgical Generator subject to this correction. All Megadyne Mega Power Electrosurgical Generators are subject to this correction. FRONT VIEW OF MEGA POWER ELECTROSURGICAL GENERATOR (New Faceplate): FRONT VIEW OF MEGA POWER ELECTROSURGICAL GENERATOR (Old Faceplate): Page 5 of 7

6 REAR VIEW OF MEGA POWER ELECTROSURGICAL GENERATOR: Product Code Product Code Page 6 of 7

7 ATTACHMENT 2: Business Reply Form (BRF) Your timely response to this customer notification is requested. Please complete and this form directly to the distributor who provided this form to you at [DISTRIBUTOR ADDRESS] within 3 business days, even if you do not have the product subject to this correction. Product Inventory Please check one: We DO NOT have any Megadyne Mega Power Electrosurgical Generator subject to this correction. We have Megadyne Mega Power Electrosurgical Generator(s) subject to this correction and have informed all relevant users of this notification to only plug one active device into each channel at a time. We have posted this notification in an area for awareness to all Megadyne Mega Power Electrosurgical Generator users and confirmed the label supplied to the Biomedical Engineering Manager has been applied to the front of the generator(s). [Account Name] [Account Address] Print Name of Person Completing Business Reply Form: Telephone Number: Account Number: Date: Signed*: *Your signature provides confirmation that you have received and understood this notification Your comments are welcome. Page 7 of 7

URGENT: VOLUNTARY RECALL OF ANSELL SANDEL WEIGHTED SAFETY SCALPEL

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