NEXGEN OSCILLATOR BLADE, BRAZOL COATED
Received Jan 11, 2008 · Event occurred Dec 13, 2007
Report 1017294-2008-00018 · MDR key 981189
Device
Generic name
Oscillator Blade, 19.5x86x1.27mm
Manufacturer
Conmed LinvatecModel number
NACatalog number
00507120100
Lot number
BBD33235
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
NA
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BLADE AND PACKAGING FOR EVALUATION. DURING TESTING, CONMED LINVATEC CONFIRMED THE REPORTED PROBLEM. A DEFORMITY IS NOTED IN THE PROXIMAL CORNER OF PACKAGING TRAY CONTAINING THIS STERILE BLADE. FURTHER INVESTIGATION FOUND THE PACKAGING COMPROMISED. AN INVESTIGATION FOR THIS FAILURE REMAINS IN PROCESS.
Description of Event or Problem
OUR FOREIGN DISTRIBUTOR REPORTED THAT THE PACKAGING CONTAINING THIS STERILE BLADE HAS A DEFORMITY. THERE WAS NO PT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS EVENT.