MalfunctionFAM
OLYMPUS
Received Feb 6, 2001
Report MW1021027 · MDR key 315360
Device
Generic name
Osf-2 Flexible Sigmoidoscope
Manufacturer
Olympus America, Inc.Model number
OSF-2Catalog number
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Lot number
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Product problems
Patient
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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.