inforMED
MalfunctionDWH

TERUMO STERNAL SAW

Received Apr 21, 2008 · Event occurred Mar 25, 2008

Report 1828100-2008-00228 · MDR key 1032167

Device

Generic name

Sternum Saw

Model number

6090

Catalog number

6090

Product problems

  • Device Inoperable

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING USE IN A CARDIOPULMONARY BYPASS PROCEDURE, THE STERNAL SAW WAS NOISY AND DID NOT CUT AS EXPECTED. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

EVAL IN PROGRESS BUT NOT CONCLUDED.