MalfunctionDWH
TERUMO STERNAL SAW II
Received Mar 20, 2008 · Event occurred Feb 19, 2008
Report 1828100-2008-00146 · MDR key 1047602
Device
Generic name
Sternum Saw (power Unit)
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
15670Catalog number
15670
Product problems
- Failure, intermittent
- Noise
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING CARDIOPULMONARY BYPASS SURGERY, THE STERNAL SAW WAS OBSERVED TO BE NOISIER THAN EXPECTED, AND EXHIBITED WOBBLE IN THE SHAFT CONNECTION. THERE WERE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT CONCLUDED.