PlainHospital

OLYMPUS WINTER & IBE GMBH

Manufacturer adverse-event records for OLYMPUS WINTER & IBE GMBH 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 · 1996–2026 · heavy-book · typical Death-code · injury-light

Injury-mix signature

OLYMPUS WINTER & IBE GMBH is lighter on Injury codes

Injury-coded event_type share is 5.1% (injury-light tercile) beside 0.09% Death-coded (typical). Volume band: heavy.

What the Injury-mix reading shows for OLYMPUS WINTER & IBE GMBH

The standout signal for OLYMPUS WINTER & IBE GMBH is Injury-mix: 5.1% Injury-coded (injury-light) beside 0.09% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair OLYMPUS WINTER & IBE GMBH 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 22,212 (94.6% of event_type total). Peak single-year volume reaches 8,542 reports across 31 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

23,484
Total Reports
22
Event-type Death
1,188
Injury Reports
20
Device Types

Event Types

Malfunction 22,212 (94.6%)
Injury 1,188 (5.1%)
Other 53 (0.2%)
Death 22 (0.1%)
9 (0.0%)

Patient Outcomes

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

21,931 (93.5%)
Required Intervention 710 (3.0%)
Other 430 (1.8%)
R 140 (0.6%)
Hospitalization 130 (0.6%)
O 29 (0.1%)
H 27 (0.1%)
Death 18 (0.1%)
L 10 (0.0%)
S 9 (0.0%)
Life Threatening 5 (0.0%)
D 4 (0.0%)
Disability 3 (0.0%)

Devices (20)

Device Reports
Laparoscope, Gynecologic (And Accessories) 9,566
Hysteroscope (And Accessories) 4,147
Urethroscope 1,634
Endoscope, Rigid 1,154
Electrosurgical, Cutting & Coagulation & Accessories 1,116
Endoscope, Accessories, Narrow Band Spectrum 1,059
Laparoscope, General & Plastic Surgery 944
Electrode, Electrosurgical, Active, Urological 873
Endoscope, Ac-Powered And Accessories 626
Arthroscope 403
Resectoscope 358
Mediastinoscope, Surgical 331
Ureteroscope And Accessories, Flexible/Rigid 287
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) 214
Nasopharyngoscope (Flexible Or Rigid) 122
Cystoscope And Accessories, Flexible/Rigid 93
Endoscopic Access Overtube, Gastroenterology-Urology 85
Telescope, Rigid, Endoscopic 63
Electrode, Electrosurgical 60
Kit, Nephroscope 59

Yearly Trend

96
1996: 3
97
1997: 13
98
1998: 28
99
1999: 32
00
2000: 42
01
2001: 43
02
2002: 27
03
2003: 40
04
2004: 31
05
2005: 9
06
2006: 10
07
2007: 30
08
2008: 33
09
2009: 19
10
2010: 40
11
2011: 47
12
2012: 108
13
2013: 79
14
2014: 93
15
2015: 91
16
2016: 141
17
2017: 304
18
2018: 172
19
2019: 210
20
2020: 303
21
2021: 348
22
2022: 786
23
2023: 3,251
24
2024: 7,022
25
2025: 8,542
26
2026: 1,587

Read our methodology - how this data is sourced, computed, and verified.