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MacroLyte Premie Dispersive Electrode(2014-05-12)
- Starting date:
- May 12, 2014
- Posting date:
- June 5, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39813
Recalled Products
MacroLyte Premie Dispersive Electrode
Reason
Through the Conmed corporation complaint handling system, Conmed received six (6) complaints regarding sparking, no output and burning at the cord set connection. The initial complaint was received on 04/11/2014. The complaints were for the gel possibly making contact with an internal staple and this may cause no output, sparking and heat buildup between the staple and foil contact surface. One patient in Japan was reportedly to have received a burn. Conmed confirmed instances where the gel contact with the internal staple causes the staple to corrode over time. Corroded staples may fail upon device activation, causing a burn through the foam which covers the staple.
Affected products
MacroLyte Premie Dispersive Electrode
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
440-2400
Companies
- Manufacturer
-
Conmed Corporation
525 French Road
Utica
13502
New York
UNITED STATES