Olympus Winter & IBE Gmbh
FDA adverse event reports naming Olympus Winter & IBE Gmbh as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: OLYMPUS WINTER & IBE GMBH.
- Total reports
- 26,599
- Deaths
- 22
- Injuries
- 1,194
- Malfunctions
- 25,321
Reports per year
10812
7913
9314
9115
14116
30417
17218
21019
30320
34821
78622
3,25123
7,02224
8,54225
4,70226
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
- Laparoscope, Gynecologic (And Accessories)HET11,504
- Hysteroscope (And Accessories)HIH4,530
- UrethroscopeFGC1,750
- Endoscope, RigidGCM1,400
- Endoscope, Accessories, Narrow Band SpectrumNWB1,195
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI1,127
- Laparoscope, General & Plastic SurgeryGCJ1,036
- Electrode, Electrosurgical, Active, UrologicalFAS878
- Endoscope, Ac-Powered And AccessoriesGCP652
- ArthroscopeHRX443
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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