MalfunctionDWH
TERUMO STERNAL SAW II
Received Feb 16, 2009
Report 1828100-2009-00068 · MDR key 1314049
Device
Generic name
Sternum Saw
Manufacturer
Terumo Cardiovascular Systems CorpModel number
15665Catalog number
15665
Product problems
- Device Inoperable
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CONNECTING PIN TO THE MOTOR UNDERGOES A LOT OF WEAR AND TEAR WHICH RESULTED IN THE REPLACEMENT OF THE WHOLE STERNAL SAW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT. NOTE: THE DATE OF THE EVENT WAS NOT REPORTED.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT CONCLUDED.