MalfunctionDWH
TERUMO STERNAL SAW II
Received Apr 21, 2010 · Event occurred Mar 26, 2010
Report 1828100-2010-00246 · MDR key 1675285
Device
Generic name
Sternum Saw
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
5590Catalog number
5590
Product problems
- Device Inoperable
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 ALTERNATIVE 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.