MalfunctionLMB
OLYMPUS
Received Jul 18, 2003
Report 2429304-2003-00014 · MDR key 473475
Device
Generic name
Software
Manufacturer
Olympus America, Inc.Model number
IMAGE MANAGERCatalog number
NA
Lot number
NA
Product problems
- Computer Software Problem
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE NOTE FINDINGS IN IMAGEMANAGER ARE NOT BEING CARRIED OVER TO THE REFERRAL LETTER WHEN SESSILE POLYP FINDINGS ARE USED. THERE WAS NO ALLEGATION OF HARM.
Remedial action
- Recall