inforMED
MalfunctionFAM

OLYMPUS

Received Feb 6, 2001

Report MW1021027 · MDR key 315360

Device

Generic name

Osf-2 Flexible Sigmoidoscope

Model number

OSF-2

Catalog number

*

Lot number

*

Product problems

Patient

*

Narrative

Description of Event or Problem

OLYMPUS OSF-2 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPES ARE NO LONGER "STANDARD OF CARE" BECAUSE THE SIGMOIDOSCOPE CANNOT BE CLEANED PROPERLY - ACCORDING TO THE MFR. THERE IS THE POTENTIAL OF PATIENT-TO-PATIENT CONTAMINATION. HOWEVER, OLYMPUS HAS NOT ISSUED A WARNING ON RECALL TO THOSE WHO PURCHASED THERE SCOPES.