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2026 data FDA MAUDE openFDA FDA Class II

Scaler, Ultrasonic

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 §872.4850 (Dental panel).

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FDA MAUDE casebook

openFDA event book Scaler, Ultrasonic LIGHT-BOOK · MAUDE

#381 of 1000 · 3,281 reports · 1994–2026

  • BOOK 3,281 reports
  • RANK #381 of 1000
  • DEATH 3 death-typed
  • INJ 127 injury-typed
  • MALF 3,135 malfunction
  • SPAN 1994–2026
  • PEAK 2017: 356
  • PHOTO Injector And Syringe

Nearest event-volume peer: Injector And Syringe, Angiographic (34 report gap)

Scaler, Ultrasonic sits #381 of 1000 among tracked device types with 3,281 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

Scaler, Ultrasonic carries 95.6% MALFUNCTION-coded reports, 30.7pp above 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 3.9% corpus 30.3% · below corpus mean (-26.4 pp)
  • MALF 95.6% corpus 64.8% · above corpus mean (+30.7 pp)

Lead product-problem code Overheating of Device is 35% of coded problems · Top event location is 52% of location-tagged rows .

Scaler, Ultrasonic in the event-volume neighbourhood

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

reports

What this shows Scaler, Ultrasonic carries 3,281 MAUDE reports, ranked #381 of 1000.

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

Event Types

Malfunction 3,135 (95.6%)
Injury 127 (3.9%)
Other 13 (0.4%)
3 (0.1%)
Death 3 (0.1%)

Patient Outcomes

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

3,074 (93.3%)
Other 127 (3.9%)
Required Intervention 40 (1.2%)
Hospitalization 15 (0.5%)
R 11 (0.3%)
Disability 10 (0.3%)
L 4 (0.1%)
S 4 (0.1%)
O 3 (0.1%)
Death 3 (0.1%)
H 2 (0.1%)
Life Threatening 1 (0.0%)

Top Product Problems

Overheating of Device 1,351
Break 761
Restricted Flow rate 509
Material Separation 393
No Flow 292
Temperature Problem 148
Tip breakage 99
Detachment Of Device Component 49
Device, removal of (non-implant) 43
Insufficient Device Problem Information 25
Device Operates Differently Than Expected 21
Fracture 20
Material Fragmentation 20
Infusion or Flow Problem 19
Unknown (for use when the device problem is not known) 15
Device, or device fragments remain in patient 14
Power Problem 13
Improper Flow or Infusion 12
Vibration 12
Adverse Event Without Identified Device or Use Problem 11

Yearly Trend

94
1994: 2
95
1995: 2
96
1996: 2
97
1997: 6
98
1998: 1
99
1999: 2
00
2000: 2
01
2001: 5
03
2003: 6
04
2004: 3
05
2005: 151
06
2006: 127
07
2007: 12
08
2008: 58
09
2009: 108
10
2010: 79
11
2011: 5
12
2012: 3
13
2013: 6
14
2014: 37
15
2015: 135
16
2016: 169
17
2017: 356
18
2018: 289
19
2019: 302
20
2020: 164
21
2021: 166
22
2022: 165
23
2023: 210
24
2024: 219
25
2025: 289
26
2026: 200

Reports in 2025 (289) held close to the prior two-year average of 215.

Related Entities for Scaler, Ultrasonic

Event Locations

1,720 (52.4%)
I 1,502 (45.8%)
NO INFORMATION 18 (0.5%)
OUTPATIENT TREATMENT FACILITY 17 (0.5%)
OTHER 11 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.1%)
UNKNOWN 4 (0.1%)
HOSPITAL 3 (0.1%)
INVALID DATA 2 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Scaler, Ultrasonic: 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 (3,281 here).

Injector And Syringe, Angiographic 3,315 Chair, With Casters 3,241 Monitor, Bed Patient 3,238 Stimulator, Electrical, Evoked Response 3,228

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Scaler, Ultrasonic 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 Scaler, Ultrasonic; 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.