inforMED
MalfunctionEQH

MAXENON XI 300

Received Apr 23, 2014 · Event occurred Apr 2, 2014

Report 3788106 · MDR key 3788106

Device

Generic name

Light, Surgical, Fiberoptic

Manufacturer

Qed, Inc

Model number

3010

Catalog number

*

Lot number

*

Product problems

  • Thermal Decomposition of Device
  • Device Emits Odor

Patient

44 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WHILE PERFORMING MASTECTOMY, SURGEON USED LIGHTED RETRACTOR WITH STORZ LIGHT CORD THAT WAS ATTACHED TO LIGHT SOURCE. A FEW MINUTES LATER, BURNING SMELL CAME FROM LIGHT SOURCE AND LIGHT CORD. TIP OF LIGHT CORD WHERE IT WAS PLUGGED IN TO LIGHT SOURCE LOOKED BURNED.