MalfunctionJOS

COVIDIEN EDGE

Received Jun 28, 2011 · Event occurred Jun 10, 2011

Report MW5021176 · MDR key 2147444

Device

Generic name

Insulated Blade Electrode

Manufacturer

Covidien

Model number

E1455-6

Lot number

206383X

Product problems

Defective Device

Patient

16 YR

Burn, Thermal

Narrative

Description of Event or Problem

PT UNDERGOING TONSILLECTOMY AND DURING PROCEDURE EXPERIENCED COMPLICATIONS OF BOVIE BURNS ON THE RIGHT TONGUE AND LOWER LIP. UPON INSPECTION OF THE BOVIE REVEALED A DEFECT IN THE PLASTIC SHEATH COVERING THE EXTENDED TIP OF BOVIE.