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Gyrus Bovie Electrosurgical Generators - Possible Fire Hazard - Notice to Hospitals

Starting date:
February 7, 2014
Posting date:
February 7, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Fire Hazard
Audience:
Healthcare Professionals
Identification number:
RA-37973

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Issued Important Safety Information on Gyrus Bovie Electrosurgical Generators

February 7, 2014

To: Hospital Chief of Surgical Staff; Hospital Chief of Staff

Please distribute to the relevant Departments of Surgery, Emergency Medicine, and/or other Departments as required and other involved professional staff and post this NOTICE in your institution.

Subject: Possible fire hazard with Gyrus Bovie Electrosurgical Generators

Health Canada is providing this notice to inform you of a possible fire hazard with Bovie Electrosurgical Generators made by Gyrus ACMI Inc. These generators are used in electro-surgery to deliver electrical energy through cables to cut or coagulate tissues and vessels. There have been reports that the Reusable Active Cords used with the generators were smoking and catching fire. It is not clear whether the generators could have contributed to the reported incidents. It is recommended that healthcare facilities test the generators to identify the potential safety hazard.

  • There is a risk of smoke, electrical shock and fire associated with the Reusable Active Cords (RAC-B) used with the Gyrus Bovie Electrosurgical Generator. There is a concern that the generators could have contributed to the incidents.
  • Health Canada recommends that healthcare facilities that own Gyrus Bovie Electrosurgical Generators test their devices at least once a year to ensure that they meet the device's output specifications. Please refer to the section on the Recommended Tests. 
  • If the Gyrus Bovie generators are not compliant with the output specifications, Healthcare facilities should consider removing them from service.  

Background information

In November 2013, Gyrus ACMI Inc. issued a customer letter through its importer, Olympus Canada Inc., after receiving reports that the Reusable Active Cords (“cables”) used with their Bovie Electrosurgical Generator were smoking and catching fire. Gyrus ACMI cautioned users that the cables have a restricted service life and should not be used for more than one year.  Users were advised that damage or wear to the cables may compromise the integrity of the insulation, resulting in sparking, smoke, and the risk of fire or electrical shock. The affected cable model is RAC-B with lot numbers AA through MP or AR, BR. 

It was not clear whether the Gyrus Bovie generator could have contributed to the cable fires. Health Canada has not received any evidence that the generators comply with the current electrical safety standards. Gyrus ACMI withdrew its licence for the generators and has informed Health Canada that they have not sold any of these generators in Canada since 2007.  However, a few generators could still be in service in Canadian healthcare facilities. Health Canada recommends that users test their Gyrus Bovie generators at least once a year to ensure that the devices remain compliant with their output specifications. This is a precautionary measure; Health Canada has not received recent reports of incidents or malfunctions related to these generators.

The specific models of the Gyrus Bovie Electrosurgical Generators affected are:

Bovie 400-CT Electrosurgical Unit
Bovie CSV Electrosurgical Generator
Bovie Specialist Electrosurgical Generator
Bovie X-10 Electrosurgical Unit
Bovie X-15 Electrosurgical Generator
Bovie X-40 Electrosurgical Generator

Recommended Tests

Health care facilities are recommended to conduct performance tests for Gyrus Bovie Electrosurgical Generators in reference to IEC standard 60601-2-2:2009-Ed.5.0 “Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories”.  Tests for maximum voltage output are described in clause 201.12.1.103.

Reporting adverse events

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of adverse incidents associated with Gyrus Bovie Electrosurgical Generators should be reported to Health Canada at the following address:

Any suspected adverse incident can be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline: 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738