MalfunctionDWH
TERUMO STERNAL SAW
Received May 15, 2008 · Event occurred Apr 24, 2008
Report 1828100-2008-00273 · MDR key 1046464
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 IN A CARDIOPULMONARY BYPASS PROCEDURE, THE STERNAL SAW WAS NOISY AND DID NOT CUT AS EXPECTED. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT CONCLUDED.