MalfunctionDWH
TERUMO STERNAL SAW II
Received May 7, 2008 · Event occurred Apr 10, 2008
Report 1828100-2008-00255 · MDR key 1039949
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 CARDIOPULMONARY BYPASS SURGERY, THE STERNAL SAW STOPPED WORKING BEFORE THE INCISION WAS COMPLETED. AN ALTERNATE DEVICE WAS EMPLOYED AND THE PROCEDURE CONCLUDED. THERE WERE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT CONCLUDED.