OLYMPUS
Received Jul 10, 2000 · Event occurred Jun 12, 2000
Report 8010047-2000-00040 · MDR key 285342
Device
Generic name
Sigmoidoscope
Manufacturer
The Olympus Optical Co. LtdModel number
OSF-3Catalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Pain
- Perforation
- Colostomy
- Hospitalization required
Narrative
Description of Event or Problem
A FEW HOURS AFTER THE SECOND PROCEDURE WAS COMPLETED ON 6/12/00, THE PT CALLED THE PHYSICIAN WITH COMPLAINTS OF CHILLS, FEVER AND BLEEDING. THE PHYSICIAN DID NOT PERFORM A FOLLOW-UP EXAMINATION ON THE PT - THEY RECOMMENDED THAT THE PT BE HOSPITALIZED FOR FOLLOW UP TREATMENT, IF NECESSARY. ON 6/30/00, THE PHYSICIAN STATED THAT ALTHOUGH THE PT HAD MULTIPLE SYMPTOMS, THEY WERE UNABLE TO DETERMINE WHY THE PT BECAME ILL.
Description of Event or Problem
TWO ROUTINE FLEXIBLE SIGMOIDOSCOPY EXAMINATIONS WERE PERFORMED IN A PHYSICIANS OFFICE ON 6/2/00. FOLLOWING THE FIRST PROCEDURE THE PT WENT HOME BUT CALLED THE PHYSICIAN SOMETIME LATER COMPLAINING THAT HE/SHE WAS IN PAIN. WHEN THE PT RETURNED FOR EXAMINATION, THE PHYSICIAN NOTICED A PERFORATION OF THE SIGMOID COLON. THE PT WAS ADMITTED TO THE HOSP WHERE A TEMPORARY COLOSTOMY WAS PERFORMED. THE PHYSICIAN MENTIONED THAT THE PT WILL HAVE THE COLOSTOMY REVERSED AT A LATER DATE.