OLYMPUS
Received Dec 6, 2000
Report 8010047-2000-00096 · MDR key 307871
Device
Generic name
Sigmoidoscope
Manufacturer
Olympus Optical Co. Ltd.Model number
OSF-3Catalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Inflammation
- Other (for use when an appropriate patient code cannot be identified)
- Discomfort
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
COMPLAINT DESCRIPTION: AN OFFICE PHYSICIAN REPORTED THAT FOUR PTS EXPERIENCED DISCOMFORT AND SYMPTOMS OF COLITIS FOLLOWING SIGMOIDOSCOPY PROCEDURES. MEDICAL TREATMENT WAS REQUIRED FOR THE FOUR ILL PTS. NOTE: WHEN THE OLYMPUS TECHNICAL SERVICE SUPERVISOR VISITED THE OFFICE ON 11/07/2000, THE PHYSICIAN EXPLAINED THAT OSF-3 WAS USED FOR THE SIGMOIDOSCOPY PROCEDURES ASSOCIATED WITH PT INFECTIONS. ON OR ABOUT 11/28/2000, OSF-3 WAS DELIVERED TO THE OLYMPUS REPAIR CENTER. THE PHYSICIAN NOTIFIED THE SUPERVISOR THAT THE FIRST OSF-3 WAS NOT RELATED TO THE INFECTIONS AS INITIALLY REPORTED. SOME DETAILS OF THE INITIAL VISIT AND INVESTIGATION OF OSF-3 ARE BEING PROVIDED AS BACKGROUND.