MalfunctionDWH
TERUMO STERNAL SAW II
Received Aug 26, 2006 · Event occurred Jul 28, 2006
Report 1828100-2006-00332 · MDR key 776127
Device
Generic name
Sternum Saw
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
15670Catalog number
15670
Lot number
*
Product problems
- Heat
- Motor failure
- Noise
Patient
*
- 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 MADE A GRINDING NOISE AND BECAME HOT TO THE TOUCH. THE SAW MOTOR SPEED EXHIBITED VARIABLE RPM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION BEGUN, BUT NO CONCLUSIONS HAVE BEEN REACHED.