MAST QUADRANT RETRACTOR SYSTEM
Received Jul 3, 2008 · Event occurred May 23, 2008
Report 1030489-2008-00308 · MDR key 1070061
Device
Generic name
Illumination System
Manufacturer
Warsaw Orthopedic Inc.Model number
NACatalog number
9560658
Lot number
W08B1264
Product problems
- Overheating of Device
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY WHILE USING THE ILLUMINATION SYSTEM, THE CABLE MELTED, CREATING SMOKE/HEAT AND WOULD NOT FUNCTION PROPERLY. NO PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
THE LIGHT CABLE WAS RETURNED TO MEDTRONIC FOR EVALUATION. A VISUAL EXAMINATION OF THE CABLE CONFIRMS HIGH TEMPS PRESENT AT THE LIGHT SOURCE ATTACHMENT END. THIS SUGGESTS THE USE OF A MACHINE WITH GREATER THAN THE 100W INSTRUCTED ON THE PACKAGING. PACKAGE LABELING INDICATES THAT THE RECOMMENDED LIGHT SOURCE UTILIZES 100W LIGHT SOURCES AND 5MM OPTIC CABLES. USE OF LARGER CABLES AND/OR HIGHER WATTAGE LIGHT SOURCES MAY RESULT IN HIGH TEMPERATURES ON THE METAL CONNECTION TO THE LIGHT CABLE, WHICH MAY RESULT IN INJURY TO PATIENT OR STAFF AND DAMAGE TO PRODUCT.