InjuryDWH
SARNS STERNAL SAW II
Received Dec 15, 2000 · Event occurred Oct 25, 2000
Report 1828100-2000-00015 · MDR key 308988
Device
Generic name
Sternal Saw
Manufacturer
Terumo Cardiovascular SystemsModel number
98-0702-0597-0Catalog number
5590
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
HOSP OBSERVED INCREASED INCIDENCE OF STERNAL WOUND INFECTIONS. ONE COMPONENT POTENTIALLY ASSOCIATED WITH THIS EVENT WAS THE STERNAL SAW'S ADEQUATE CLEANING AND MECHANICAL INTEGRITY. ON 11/21/00 THE HOSP CONCLUDED THAT USE OF THE DEVICE MAY HAVE CONTRIBUTED TO THE EVENT.