OLYMPUS MEDICAL SYSTEMS CORP.

Manufacturer adverse-event records for OLYMPUS MEDICAL SYSTEMS CORP. 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 · 2009–2026 · heavy-book · typical Death-code · balanced

Volume signature

OLYMPUS MEDICAL SYSTEMS CORP. sits in the heavy MAUDE book

OLYMPUS MEDICAL SYSTEMS CORP. accounts for 51,074 FDA MAUDE reports (#71 of 443, heavy-book tercile). Death-coded event_type share is 0.35% (typical); Injury share 9.4% (balanced).

What the volume reading shows for OLYMPUS MEDICAL SYSTEMS CORP.

The standout signal for OLYMPUS MEDICAL SYSTEMS CORP. is filing volume: 51,074 adverse-event reports in FDA MAUDE (#71 of 443, heavy-book). Death-coded event_type share sits at 0.35% (typical).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair OLYMPUS MEDICAL SYSTEMS CORP. 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 46,063 (90.2% of event_type total). Peak single-year volume reaches 16,091 reports across 18 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

51,074
Total Reports
178
Event-type Death
4,799
Injury Reports
20
Device Types

Event Types

Malfunction 46,063 (90.2%)
Injury 4,799 (9.4%)
Death 178 (0.3%)
Other 20 (0.0%)
14 (0.0%)

Patient Outcomes

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

46,049 (88.5%)
Other 3,483 (6.7%)
Required Intervention 793 (1.5%)
R 562 (1.1%)
O 385 (0.7%)
Hospitalization 366 (0.7%)
Death 163 (0.3%)
H 88 (0.2%)
Life Threatening 40 (0.1%)
D 32 (0.1%)
L 31 (0.1%)
Disability 7 (0.0%)
S 5 (0.0%)
Congenital Anomaly 2 (0.0%)

Yearly Trend

09
2009: 6
10
2010: 4
11
2011: 20
12
2012: 38
13
2013: 30
14
2014: 96
15
2015: 657
16
2016: 1,971
17
2017: 2,709
18
2018: 3,233
19
2019: 4,471
20
2020: 10,415
21
2021: 16,091
22
2022: 11,159
23
2023: 57
24
2024: 52
25
2025: 55
26
2026: 10