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2026 data FDA MAUDE openFDA FDA Class II

Unit, Cryosurgical, Accessories

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 §878.4350 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Unit, Cryosurgical, Accessories LIGHT-BOOK · MAUDE

#385 of 1000 · 3,228 reports · 1994–2026

  • BOOK 3,228 reports
  • RANK #385 of 1000
  • DEATH 57 death-typed
  • INJ 844 injury-typed
  • MALF 2,231 malfunction
  • SPAN 1994–2026
  • PEAK 2019: 455
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Electrical, Evoked Response (0 report gap)

Unit, Cryosurgical, Accessories sits #385 of 1000 among tracked device types with 3,228 MAUDE reports spanning 1994–2026. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Unit, Cryosurgical, Accessories carries 69.1% MALFUNCTION-coded reports, 4.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.8% corpus 1.5% · near corpus mean (+0.3 pp)
  • INJ 26.1% corpus 30.3% · below corpus mean (-4.1 pp)
  • MALF 69.1% corpus 64.8% · above corpus mean (+4.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 18% of coded problems · Top event location is 51% of location-tagged rows .

Unit, Cryosurgical, Accessories in the event-volume neighbourhood

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

reports

What this shows Unit, Cryosurgical, Accessories carries 3,228 MAUDE reports, ranked #385 of 1000.

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

Event Types

Malfunction 2,231 (69.1%)
Injury 844 (26.1%)
Other 70 (2.2%)
Death 57 (1.8%)
26 (0.8%)

Patient Outcomes

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

1,768 (50.8%)
Other 741 (21.3%)
Required Intervention 449 (12.9%)
Hospitalization 168 (4.8%)
R 148 (4.2%)
Death 53 (1.5%)
O 38 (1.1%)
L 27 (0.8%)
H 25 (0.7%)
Life Threatening 23 (0.7%)
S 18 (0.5%)
Disability 16 (0.5%)
D 7 (0.2%)
C 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 487
Device Operates Differently Than Expected 341
Appropriate Device Problem Term/Code Not Available 224
Temperature Problem 195
Excessive Cooling 193
Insufficient Device Problem Information 149
Break 145
Gas/Air Leak 124
Thermal Decomposition of Device 119
Insufficient Cooling 118
Leak/Splash 102
Defective Device 97
Unknown (for use when the device problem is not known) 91
Material Rupture 70
Mechanical Problem 64
Use of Device Problem 55
Defective Component 54
Insufficient Heating 54
Therapeutic or Diagnostic Output Failure 53
Device Displays Incorrect Message 44

Yearly Trend

94
1994: 5
95
1995: 6
96
1996: 4
97
1997: 11
98
1998: 10
99
1999: 12
00
2000: 9
01
2001: 10
02
2002: 8
03
2003: 24
04
2004: 52
05
2005: 26
06
2006: 15
07
2007: 23
08
2008: 29
09
2009: 21
10
2010: 173
11
2011: 61
12
2012: 91
13
2013: 91
14
2014: 54
15
2015: 97
16
2016: 143
17
2017: 216
18
2018: 208
19
2019: 455
20
2020: 277
21
2021: 213
22
2022: 230
23
2023: 164
24
2024: 141
25
2025: 174
26
2026: 175

Reports in 2025 (174) held close to the prior two-year average of 153.

Related Entities for Unit, Cryosurgical, Accessories

Event Locations

1,662 (51.5%)
I 1,396 (43.2%)
HOSPITAL 93 (2.9%)
NO INFORMATION 21 (0.7%)
HOME 16 (0.5%)
NOT APPLICABLE 9 (0.3%)
OTHER 8 (0.2%)
OUTPATIENT TREATMENT FACILITY 7 (0.2%)
UNKNOWN 7 (0.2%)
AMBULATORY SURGICAL FACILITY 5 (0.2%)
INVALID DATA 3 (0.1%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Unit, Cryosurgical, Accessories: 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 (3,228 here).

Stimulator, Electrical, Evoked Response 3,228 Monitor, Bed Patient 3,238 Chair, With Casters 3,241 Integrated Continuous Glucose Monitoring Sy… 3,214

Similar death-typed counts

Nearest other device types by death-typed report count (57 here), distinct from the volume row.

Prosthesis 58 Pump, Infusion, Elastomeric 58 Appliance 59 Bottle, Collection, Vacuum 55

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

Disclaimer: MAUDE figures for Unit, Cryosurgical, Accessories 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 Unit, Cryosurgical, Accessories; 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.