inforMED
MalfunctionHTT

QUADCUT

Received Oct 27, 2011 · Event occurred Oct 27, 2011

Report 2316085 · MDR key 2316085

Device

Generic name

Straightshot Blade

Manufacturer

Medtronic Ent

Model 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.