inforMED
InjuryFSZ

MAST QUADRANT RETRACTOR SYSTEM

Received Apr 10, 2014 · Event occurred Mar 11, 2014

Report 1030489-2014-02142 · MDR key 3738344

Device

Generic name

Light, Surgical, Carrier

Manufacturer

Warsaw Orthopedics

Model number

NA

Catalog number

9560658

Lot number

0292423W

Product problems

  • Overheating of Device

Patient

00064 YR

  • Burn(s)

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR DLIF AT L2-3. THE SURGEON USED A LIGHT SOURCE AND WHEN IT WAS REMOVED FROM THE TUBE THE SURGEON PLACED THE LIGHT SOURCE ON THE DRAPE WHICH SUBSEQUENTLY BURNED THE PATIENT ON THE SHOULDER AREA. THE BURN WAS TREATED AND THERE WERE NO FURTHER COMPLICATIONS.

Additional Manufacturer Narrative

(B)(4). LOCATION: HOSPITAL . THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.