Olympus Medical Systems Corp.
FDA adverse event reports naming Olympus Medical Systems Corp. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: OLYMPUS MEDICAL SYSTEMS CORP..
- Total reports
- 51,100
- Deaths
- 178
- Injuries
- 4,804
- Malfunctions
- 46,084
Reports per year
3812
3013
9614
65715
1,97116
2,70917
3,23318
4,47119
10,41520
16,09121
11,15922
5723
5224
5525
3626
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET11,518
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI6,839
- Colonoscope And Accessories, Flexible/RigidFDF3,529
- Duodenoscope And Accessories, Flexible/RigidFDT3,446
- Endoscope, Accessories, Narrow Band SpectrumNWB3,215
- Gastroscope And Accessories, Flexible/RigidFDS3,121
- Bronchoscope (Flexible Or Rigid)EOQ2,915
- Laparoscope, General & Plastic SurgeryGCJ2,523
- Endoscopic Ultrasound System, Gastroenterology-UrologyODG2,222
- Instrument, Ultrasonic SurgicalLFL1,573
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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