OLYMPUS
Received Nov 10, 2000
Report 2429304-2000-00002 · MDR key 305053
Device
Generic name
Software
Manufacturer
Olympus America, Inc.Model number
IMAGEMANAGER, VERSION 6.3Catalog number
NA
Lot number
NA
Product problems
- Computer Software Problem
- Off-Label Use
Patient
UNKNOWN
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
A HOSP PHYSICIAN REPORTED THAT DETAILS OF A PT EXAMINATION (PT "X") WERE ENTERED INTO AN OLYMPUS SOFTWARE PROGRAM, ENDO WORKS, VERSION 6.3. ACCORDING TO THE PHYSICIAN, THE REPORT PRINTED CORRECTLY. THE PHYSICIAN EXPLAINED THAT WHEN THE REPORT WAS UPLOADED FROM THE ENDO WORKS SYSTEMS TO THE HOSP'S COMPUTER PROGRAM UNDER PT X'S NAME, THE REPORT HAD THE SAME OF ANOTHER PT (PT A). HOSP PERSONNEL DO NOT KNOW PT A. NEXT, WHEN THE PHYSICIAN ATTEMPTED TO PULL UP THE REPORT OF PT X IN THE ENDO WORKS SYSTEM, HE WAS STILL GETTING THE TEXT REPORT FOR PT A; THE IDENTIFIERS AND PICTURES WERE OF PT X. NOTE THAT THE PHYSICIAN MENTIONED EARLIER THAT THE INITIAL REPORT PRINTED CORRECTLY FOR PT X.