MalfunctionDWH
TERUMO STERNAL SAW II
Received Jan 4, 2008 · Event occurred Dec 5, 2007
Report 1828100-2008-00029 · MDR key 975190
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
THE USER REPORTED ONLY THAT THE STERNAL SAW WAS NOT WORKING PROPERLY. IT IS NOT KNOWN AT THE TIME OF THIS REPORT IF THE EVENT OCCURRED DURING MAINTENANCE OR DURING USE OF THE DEVICE. THE NATURE OF THE MALFUNCTION WAS ALSO NOT REPORTED. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT CONCLUDED.