MalfunctionDWH
TERUMO STERNAL SAW II
Received Dec 18, 2008
Report 1828100-2008-00616 · MDR key 1277469
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
Additional Manufacturer Narrative
NOTE: THE FAILURE MODE COULD NOT BE DUPLICATED. WHEN THE STERNAL SAW WAS TESTED, IT PERFORMED ACCORDING TO SPECIFICATIONS.
Description of Event or Problem
DURING A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE PLACE THE STERNAL SAW STOPPED WORKING DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT REPORTED AS A RESULT OF THIS EVENT. NOTE: THE DATE OF THE EVENT WAS NOT REPORTED.