MalfunctionDWH
TERUMO STERNAL SAW II
Received Feb 4, 2010 · Event occurred Jan 11, 2010
Report 1828100-2010-00028 · MDR key 1621241
Device
Generic name
Sternum Saw Motor
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5590Catalog number
5590
Product problems
- Motor failure
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT CONCLUDED.
Description of Event or Problem
DURING USE OF THE DEVICE FOR A SURGICAL PROCEDURE, THE USER REPORTED THE STERNAL SAW STOPPED WORKING. THE PT HAD PREVIOUS HEART SURGERY AND THE STERNAL SAW ACCIDENTALLY HIT THE STERNAL WIRE, CAUSING THE SAW MOTOR TO STOP. AN ALTERNATE DEVICE WAS EMPLOYED TO CONCLUDE THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.