Endoscope, Accessories, Narrow Band Spectrum
Gastroenterology, Urology · 21 CFR 876.1500
Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.
Recent MDR events
13,919 adverse event reports on file
- VISERA ELITE XENON LIGHT SOURCEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26377
- VISERA ELITE XENON LIGHT SOURCEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26391
- EVIS EXERA III XENON LIGHT SOURCEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26398
- EVIS EXERA III XENON LIGHT SOURCEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26407
- EVIS EXERA III XENON LIGHT SOURCEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26422
- EVIS EXERA III XENON LIGHT SOURCEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26424
- EVIS EXERA II XENON LIGHT SOURCEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26428
- VISERA ELITE XENON LIGHT SOURCEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26431
- EVIS EXERA III XENON LIGHT SOURCEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26434
- EVIS EXERA III XENON LIGHT SOURCEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26440
Event type breakdown
Most-reported manufacturers
Recalls
19 recall events for this product code
- Olympus Corporation of the AmericasOpen, ClassifiedJun 5, 2025
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
Z-1911-2025 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 29, 2024
Colonoscope, Model Number CF-H180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Z-1205-2024 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 29, 2024
Colonoscope, Model Number CF-Q180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Z-1208-2024 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 29, 2024
Colonoscope, Model Number PCF-H180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Z-1209-2024 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 29, 2024
Colonoscope, Model Number PCF-H190DL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Z-1210-2024 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 29, 2024
Colonoscope, Model Number PCF-H190TL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Z-1212-2024 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 29, 2024
Colonoscope, Model Number PCF-HQ190L.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Z-1213-2024 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 29, 2024
Colonoscope, Model Number PCF-Q180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Z-1214-2024 · View FDA record ↗ - Aizu Olympus Co., Ltd.Open, ClassifiedNov 17, 2023
Colonoscope-indicated for use within the lower digestive tract (including the anus,
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0341-2024 · View FDA record ↗ - Aizu Olympus Co., Ltd.Open, ClassifiedNov 17, 2023
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon).
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0342-2024 · View FDA record ↗
Registered firms
176 firms currently registered for this product code
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Shirakawa Olympus Co., Ltd.
NISHISHIRAKAWA-GUN Fukushima, JP
Ian Jamieson Pty Ltd
Fyshwick Australian Capital Territory, AU
Medical Resale Pty Limited
Caloundra QLD Queensland, AU
Life Science Logistics, Llc
Brownsburg, IN, US
Makar Consulting Pty Ltd
Belrose New South Wales, AU
Mdtglobal, A.s.
Bratislava Bratislavsky, SK
Aizu Olympus Co., Ltd.
AIZUWAKAMATSU-SHI Fukushima, JP
Probo Medical Ltd
Gloucester Gloucestershire, GB
Arvato Se
Hamburg, DE
Nz Biomed Limited
Dunedin Otago, NZ
510(k) clearances
9 clearances for this product code
- Sonoscape Medical Corp.Sep 8, 2022
K222020 · HD-550 Video Endoscope System
- Sonoscape Medical Corp.Apr 1, 2022
K211882 · HD-550 Video Endoscope System
- Sonoscape Medical Corp.Sep 5, 2018
K173921 · HD-500 Video Endoscope System
- Olympus Corporation of the AmericasAug 7, 2014
K133538 · VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE
- Olympus Medical Systems CorporationJul 2, 2010
K100584 · EVIS EXERAII 180 SYSTEM
- Olympus Winter & Ibe GmbHJun 29, 2009
K090980 · HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
- Olympus Medical Systems CorporationMar 18, 2008
K072957 · EVIS EXERA II 180 SYSTEM
- Olympus Medical Systems CorporationSep 22, 2006
K062049 · EVIS EXERA II 180 SYSTEM