MalfunctionDWH
TERUMO STERNAL SAW II
Received Sep 15, 2009 · Event occurred Aug 18, 2009
Report 1828100-2009-00439 · MDR key 1500933
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
EVALUATION IN PROGRESS BUT NOT CONCLUDED.
Description of Event or Problem
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE BLADE GUARD WAS BENT. AN ALTERNATE DEVICE WAS EMPLOYED TO CONCLUDE THE PROCEDURE. THE USER REPORTED, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.