MalfunctionDWH
TERUMO STERNAL SAW
Received Nov 17, 2008 · Event occurred Oct 24, 2008
Report 1828100-2008-00551 · MDR key 1239586
Device
Generic name
Sternum Saw Motor
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
6090Catalog number
6090
Product problems
- Device Inoperable
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION IS IN PROGRESS, BUT NOT CONCLUDED.
Description of Event or Problem
DURING USE OF THE DEVICE IN A CARDIOPULMONARY BYPASS PROCEDURE, THE SAW MOTOR FROZE. 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.