MalfunctionDWH
TERUMO STERNAL SAW II
Received Oct 4, 2006 · Event occurred Sep 6, 2006
Report 1828100-2006-00399 · MDR key 861732
Device
Generic name
Sternum Saw
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
15670Catalog number
15670
Lot number
*
Product problems
- Motor failure
Patient
*
- No Consequences Or Impact To Patient
- No Patient Involvement
Narrative
Description of Event or Problem
DURING PREPARATION FOR USE OF THE DEVICE IN A CARDIOPULMONARY BYPASS PROCEDURE, THE SAW MOTOR INTERMITTENTLY STOPPED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION BEGUN, BUT NO CONCLUSIONS HAVE BEEN REACHED.