QUADCUT
Received Oct 27, 2011 · Event occurred Oct 27, 2011
Report 2316085 · MDR key 2316085
Device
Generic name
Straightshot Blade
Manufacturer
Medtronic EntModel number
*Catalog number
1884380HR
Lot number
0205308154
Product problems
- Fitting Problem
Patient
57 YR
- No Information
Narrative
Description of Event or Problem
WHILE SURGICAL TECH WAS SETTING UP FOR ENT EAR, NOSE, AND THROAT (SINUS SURGERY) CASE, SHE WAS UNABLE TO FIT THE CUTTING BLADE ONTO THE HANDPIECE IN ORDER TO MAKE IT FUNCTION. SHE TRIED ANOTHER BLADE FROM THE SAME LOT AND THE SAME THING HAPPENED. SHE WAS ABLE TO USE A THIRD BLADE FROM A DIFFERENT LOT WITHOUT DIFFICULTY.======================MANUFACTURER RESPONSE FOR STRAIGHTSHOT BLADE, QUADCUT (PER SITE REPORTER).======================MANUFACTURER REP REPRESENTATIVE AGREED THAT ITEM WOULD NOT FIT ONTO HANDLE. HE TOOK ALL PRODUCT WITH THAT SAME LOT #. WE HAD SAME ITEM WITH DIFFERENT LOT THAT FIT AND WORKED FINE.