MalfunctionDWH
TERUMO STERNAL SAW II
Received Nov 11, 2008 · Event occurred Oct 17, 2008
Report 1828100-2008-00544 · MDR key 1237427
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
Description of Event or Problem
DURING A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE PLACE WHERE THE BLADE FITS IN THE BOTTOM PIECE IS BROKEN AND FALLS OUT. THIS HAPPENED DURING CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.