Shirakawa Olympus Co., Ltd.
FDA adverse event reports naming Shirakawa Olympus Co., Ltd. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SHIRAKAWA OLYMPUS CO., LTD..
- Total reports
- 90,732
- Deaths
- 32
- Injuries
- 1,086
- Malfunctions
- 89,614
Reports per year
Source: FDA adverse event reports by year received, 2020–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET47,466
- Endoscopic Ultrasound System, Gastroenterology-UrologyODG10,630
- Endoscope, Accessories, Narrow Band SpectrumNWB9,036
- Cystoscope And Accessories, Flexible/RigidFAJ7,082
- Insufflator, LaparoscopicHIF4,694
- Ultrasound BronchoscopePSV4,606
- Nasopharyngoscope (Flexible Or Rigid)EOB1,877
- Laparoscope, General & Plastic SurgeryGCJ1,416
- Light Source, Endoscope, Xenon ArcGCT1,217
- Colonoscope And Accessories, Flexible/RigidFDF829
Recent recalls
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-5, Cystonephrofiberscope
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-5R, Cystonephrofiberscope
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. BF-P190, EVIS EXERA III Bronchovideoscope
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. BF-XP190, EVIS EXERA III Bronchovideoscope
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
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