MalfunctionDWH
TERUMO STERNAL SAW II
Received Feb 25, 2009 · Event occurred Jan 20, 2009
Report 1828100-2009-00065 · MDR key 1375907
Device
Generic name
Sternum Saw Motor
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
7084Catalog number
7084
Product problems
- Device Inoperable
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE IN A CARDIOPULMONARY BYPASS PROCEDURE, THE SAW MOTOR DID NOT FUNCTION. THE SAW MOTOR WAS EXCHANGED FOR ANOTHER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT CONCLUDED.