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 · typical Death-code · injury-light

Volume signature

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

AIZU OLYMPUS CO., LTD. accounts for 115,794 FDA MAUDE reports (#27 of 443, heavy-book tercile). Death-coded event_type share is 0.08% (typical); Injury share 2.2% (injury-light).

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

The standout signal for AIZU OLYMPUS CO., LTD. is filing volume: 115,794 adverse-event reports in FDA MAUDE (#27 of 443, heavy-book). Death-coded event_type share sits at 0.08% (typical).

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 113,139 (97.7% of event_type total). Peak single-year volume reaches 45,575 reports across 8 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

115,794
Total Reports
89
Event-type Death
2,566
Injury Reports
20
Device Types

Event Types

Malfunction 113,139 (97.7%)
Injury 2,566 (2.2%)
Death 89 (0.1%)

Patient Outcomes

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

112,725 (97.6%)
Required Intervention 1,100 (1.0%)
Other 1,016 (0.9%)
R 204 (0.2%)
Hospitalization 139 (0.1%)
O 124 (0.1%)
H 114 (0.1%)
Death 72 (0.1%)
D 22 (0.0%)
L 19 (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: 45,575
26
2026: 18,055