MalfunctionDWH
TERUMO STERNAL SAW I
Received Jul 6, 2010 · Event occurred Jun 16, 2010
Report 1828100-2010-00782 · MDR key 1749147
Device
Generic name
Sternum Saw
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
6090Catalog number
6090
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE SAW MOTOR SEIZED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.