SHIRAKAWA OLYMPUS CO., LTD.

Manufacturer adverse-event records for SHIRAKAWA 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 · 2020–2026 · heavy-book · quiet Death-code · injury-light

Volume signature

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

SHIRAKAWA OLYMPUS CO., LTD. accounts for 73,950 FDA MAUDE reports (#44 of 443, heavy-book tercile). Death-coded event_type share is 0.04% (quiet); Injury share 1.4% (injury-light).

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

The standout signal for SHIRAKAWA OLYMPUS CO., LTD. is filing volume: 73,950 adverse-event reports in FDA MAUDE (#44 of 443, heavy-book). Death-coded event_type share sits at 0.04% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair SHIRAKAWA 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 72,874 (98.5% of event_type total). Peak single-year volume reaches 27,170 reports across 7 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

73,950
Total Reports
32
Event-type Death
1,044
Injury Reports
20
Device Types

Event Types

Malfunction 72,874 (98.5%)
Injury 1,044 (1.4%)
Death 32 (0.0%)

Patient Outcomes

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

72,723 (98.5%)
Other 451 (0.6%)
Required Intervention 364 (0.5%)
Hospitalization 72 (0.1%)
R 63 (0.1%)
O 47 (0.1%)
H 40 (0.1%)
Death 29 (0.0%)
Life Threatening 12 (0.0%)
L 8 (0.0%)
D 4 (0.0%)
Congenital Anomaly 2 (0.0%)

Yearly Trend

20
2020: 7
21
2021: 13
22
2022: 5,422
23
2023: 14,933
24
2024: 20,764
25
2025: 27,170
26
2026: 5,641