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2026 data FDA MAUDE openFDA FDA Class II

Sterilizer, Steam

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.6880 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Sterilizer, Steam LIGHT-BOOK · MAUDE

#570 of 1000 · 1,502 reports · 1992–2026

  • BOOK 1,502 reports
  • RANK #570 of 1000
  • DEATH 1 death-typed
  • INJ 131 injury-typed
  • MALF 891 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 113
  • PHOTO Patch

Nearest event-volume peer: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (4 report gap)

Sterilizer, Steam sits #570 of 1000 among tracked device types with 1,502 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Sterilizer, Steam carries 8.7% INJURY-coded reports, 21.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 8.7% corpus 30.3% · below corpus mean (-21.6 pp)
  • MALF 59.3% corpus 64.8% · below corpus mean (-5.5 pp)

Lead product-problem code Leak/Splash is 26% of coded problems · Lead manufacturer AESCULAP AG accounts for 53% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Sterilizer, Steam in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Sterilizer, Steam carries 1,502 MAUDE reports, ranked #570 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 891 (59.3%)
434 (28.9%)
Injury 131 (8.7%)
Other 45 (3.0%)
Death 1 (0.1%)

Patient Outcomes

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

1,158 (76.7%)
Other 247 (16.4%)
Required Intervention 73 (4.8%)
Hospitalization 17 (1.1%)
R 4 (0.3%)
O 3 (0.2%)
Disability 3 (0.2%)
L 1 (0.1%)
Congenital Anomaly 1 (0.1%)
Death 1 (0.1%)
Invalid Data 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Leak/Splash 303
Fluid/Blood Leak 193
Device Operates Differently Than Expected 71
Adverse Event Without Identified Device or Use Problem 69
Device Fell 68
Component Falling 67
Use of Device Problem 49
Insufficient Device Problem Information 46
Device Tipped Over 42
Detachment of Device or Device Component 38
Smoking 36
Mechanical Problem 32
Detachment Of Device Component 30
Improper or Incorrect Procedure or Method 29
Other (for use when an appropriate device code cannot be identified) 22
Problem with Sterilization 22
Sticking 19
Noise, Audible 18
Unknown (for use when the device problem is not known) 18
Device Emits Odor 16

Yearly Trend

92
1992: 8
93
1993: 4
94
1994: 6
95
1995: 10
96
1996: 16
97
1997: 27
98
1998: 10
99
1999: 10
00
2000: 25
01
2001: 19
02
2002: 18
03
2003: 9
04
2004: 16
05
2005: 15
06
2006: 9
07
2007: 19
08
2008: 21
09
2009: 19
10
2010: 20
11
2011: 63
12
2012: 69
13
2013: 112
14
2014: 113
15
2015: 68
16
2016: 76
17
2017: 63
18
2018: 90
19
2019: 91
20
2020: 87
21
2021: 81
22
2022: 70
23
2023: 66
24
2024: 64
25
2025: 71
26
2026: 37

Reports in 2025 (71) held close to the prior two-year average of 65.

Related Entities for Sterilizer, Steam

Top Manufacturers

AESCULAP AG 19
AESCULAP AG 17

Event Locations

818 (54.5%)
I 454 (30.2%)
HOSPITAL 162 (10.8%)
INVALID DATA 22 (1.5%)
NO INFORMATION 17 (1.1%)
OTHER 11 (0.7%)
AMBULATORY SURGICAL FACILITY 7 (0.5%)
UNKNOWN 4 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.2%)
OUTPATIENT TREATMENT FACILITY 3 (0.2%)
DIALYSIS UNIT 1 (0.1%)

Compare AESCULAP AG vs AESCULAP AG →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Sterilizer, Steam: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,502 here).

Patch 1,498 Instrument, Cutting, Orthopedic 1,496 Endoscope, Rigid 1,495 Washer, Bolt Nut 1,494

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Sterilizer, Steam are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Sterilizer, Steam; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.