InjuryDWH
SARNS STERNAL SAW
Received Jan 14, 2002 · Event occurred Nov 20, 2001
Report 1828100-2002-00001 · MDR key 371650
Device
Generic name
Sternal Saw
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
98-0702-0597-0Catalog number
5590
Lot number
NA
Product problems
- Break
- Material Fragmentation
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER REPORTED THAT AS THE SAW WAS BEING USED TO OPEN THE PATIENT'S CHEST, EITHER THE SAW BLADE OR THE SAW BLADE PROTECTOR BROKE. THE BROKEN PIECES WERE REMOVED FROM THE SURGICAL FIELD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION.