MalfunctionDWH
TERUMO STERNAL SAW II
Received Oct 8, 2009 · Event occurred Sep 11, 2009
Report 1828100-2009-00499 · MDR key 1513064
Device
Generic name
Sternum Saw Motor
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
15670Catalog number
15670
Product problems
- Failure to Cut
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR A SURGICAL PROCEDURE, THE USER REPORTED THE STERNAL SAW DID NOT HAVE ENOUGH POWER TO CUT THE STERNUM. 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.
Additional Manufacturer Narrative
EVAL IN PROGRESS BUT NOT CONCLUDED.