MalfunctionMMP
DEVON LITE GLOVE LIGHT HANDLE SYSTEMS
Received Aug 18, 2015 · Event occurred Aug 3, 2015
Report 5010309 · MDR key 5010309
Device
Generic name
Cover, Barrier, Protective
Manufacturer
CovidienCatalog number
31140257
Lot number
5153101664X
Product problems
- Packaging Problem
Patient
Not reported
- Test Result
Narrative
Description of Event or Problem
CURRENT PACKAGING CURLS THE SIDE OF THE LIGHT HANDLES. LIGHT HANDLES DO NOT FLATTEN OUT WHILE IN USE. THIS RESULTS IN AN INCOMPLETE COVERING OF THE NON STERILE HANDLE WHICH COULD CAUSE CONTAMINATION OF THE SURGICAL TEAM DURING THE SURGICAL CASE. THE PACKAGING PROBLEM IS PRESENT IN MULTIPLE LOTS WITH MULTIPLE DEVICES.