MalfunctionDWH
TERUMO STERNAL SAW II
Received Jan 9, 2008 · Event occurred Dec 10, 2007
Report 1828100-2008-00016 · MDR key 977671
Device
Generic name
Sternum Saw Drive Motor
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
7084Catalog number
7084
Product problems
- Connection error
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE DRIVE CABLE WAS DIFFICULT TO ATTACH TO THE MOTOR. THE PARTIAL CONNECTION WAS SUFFICIENT TO USE THE DEVICE FOR ITS INTENDED PURPOSE. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT CONCLUDED.