AIZU OLYMPUS CO., LTD.

Manufacturer adverse-event records for AIZU OLYMPUS CO., LTD. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2019–2026 · heavy-book · quiet Death-code · injury-light

Volume signature

AIZU OLYMPUS CO., LTD. sits in the heavy MAUDE book

AIZU OLYMPUS CO., LTD. accounts for 159,910 FDA MAUDE reports (#20 of 434, heavy-book tercile). Death-coded event_type share is 0.06% (quiet); Injury share 1.7% (injury-light).

What the volume reading shows for AIZU OLYMPUS CO., LTD.

The standout signal for AIZU OLYMPUS CO., LTD. is filing volume: 159,910 adverse-event reports in FDA MAUDE (#20 of 434, heavy-book). Death-coded event_type share sits at 0.06% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair AIZU OLYMPUS CO., LTD. with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 20 device types, led in this extract by Malfunction at 157,108 (98.2% of event_type total). Peak single-year volume reaches 62,170 reports across 8 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

159,910
Total Reports
93
Event-type Death
2,709
Injury Reports
20
Device Types

Event Types

Malfunction 157,108 (98.2%)
Injury 2,709 (1.7%)
Death 93 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

154,445 (98.1%)
Required Intervention 1,174 (0.7%)
Other 1,020 (0.6%)
R 216 (0.1%)
Hospitalization 150 (0.1%)
O 124 (0.1%)
H 123 (0.1%)
Death 75 (0.0%)
D 23 (0.0%)
L 22 (0.0%)
Life Threatening 11 (0.0%)
Disability 5 (0.0%)
S 3 (0.0%)
C 1 (0.0%)

Yearly Trend

19
2019: 1
20
2020: 20
21
2021: 45
22
2022: 6,483
23
2023: 20,767
24
2024: 24,848
25
2025: 45,576
26
2026: 62,170