MalfunctionFGM
OLYMPUS
Received Aug 16, 2005 · Event occurred Jun 15, 2005
Report 8010047-2005-00089 · MDR key 703765
Device
Generic name
Heater Probe Unit
Manufacturer
Olympus Optical Co. Ltd.Model number
HPU-20Catalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Bleeding
- Hospitalization required
Narrative
Description of Event or Problem
THE HOSP REPORTED THE PT COMPLAINED OF ABDOMINAL PAIN FOR FIVE (5) DAYS FOLLOWING A PROCEDURE. ON THE FIFTH DAY, THE PT PRESENTED AT THE EMERGENCY ROOM WITH A BLEED. HOWEVER, THE PHYSICIAN PERFORMING THE PROCEDURE REPORTED THAT THE BLEED WAS MOST LIKELY CAUSED BY THE PT'S CONDITION. THE PT WAS TREATED AND RELEASED. THE MEDICAL INTERVENTION USED TO TREAT THE BLEED IS UNK.