OLYMPUS OSF-2 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-06 for OLYMPUS OSF-2 * manufactured by Olympus America, Inc..

Event Text Entries

[20524646] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW1021027
MDR Report Key315360
Date Received2001-02-06
Date of Report2001-02-06
Date Added to Maude2001-02-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameOLYMPUS
Generic NameOSF-2 FLEXIBLE SIGMOIDOSCOPE
Product CodeFAM
Date Received2001-02-06
Model NumberOSF-2
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key304956
ManufacturerOLYMPUS AMERICA, INC.
Manufacturer AddressTWO CORPORATE CTR DR MELVILLE NY 11747 US

Device Sequence Number: 2

Brand NameOLYMPUS
Generic NameOSF-2 FLEXIBLE SIGMOIDOSCOPE
Product CodeFAM
Date Received2001-02-06
Model NumberOSF-2
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key304969
ManufacturerOLYMPUS AMERICA, INC.
Manufacturer AddressTWO CORPORATE CTR DR MELVILLE NY 11747 US

Patients

Patient NumberTreatmentOutcomeDate
101. Other 2001-02-06
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