2026 data FDA MAUDE openFDA FDA Class II

Fluid Jet Removal System

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 §876.4350 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Fluid Jet Removal System LIGHT-BOOK · MAUDE

#579 of 1000 · 1,449 reports · 2018–2026

  • BOOK 1,449 reports
  • RANK #579 of 1000
  • DEATH 35 death-typed
  • INJ 751 injury-typed
  • MALF 663 malfunction
  • SPAN 2018–2026
  • PEAK 2024: 309
  • PHOTO Slide Stainer

Nearest event-volume peer: Slide Stainer, Automated (3 report gap)

Fluid Jet Removal System sits #579 of 1000 among tracked device types with 1,449 MAUDE reports spanning 2018–2026. 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 →

Injury-coded reports run above the device-type norm

Fluid Jet Removal System carries 51.8% INJURY-coded reports, 21.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.4% corpus 1.5% · above corpus mean (+0.9 pp)
  • INJ 51.8% corpus 30.3% · above corpus mean (+21.5 pp)
  • MALF 45.8% corpus 64.8% · below corpus mean (-19.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 51% of coded problems · Top event location is 84% of location-tagged rows .

Fluid Jet Removal System in the event-volume neighbourhood

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

reports

What this shows Fluid Jet Removal System carries 1,449 MAUDE reports, ranked #579 of 1000.

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

Event Types

Injury 751 (51.8%)
Malfunction 663 (45.8%)
Death 35 (2.4%)

Patient Outcomes

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

665 (41.5%)
Required Intervention 537 (33.5%)
Other 117 (7.3%)
Hospitalization 83 (5.2%)
R 75 (4.7%)
H 65 (4.1%)
Death 33 (2.1%)
O 13 (0.8%)
L 6 (0.4%)
D 4 (0.2%)
Life Threatening 3 (0.2%)
Disability 2 (0.1%)
S 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 756
Visual Prompts will not Clear 279
Display or Visual Feedback Problem 93
Connection Problem 74
Break 47
Mechanical Problem 47
No Flow 21
Mechanical Jam 19
Use of Device Problem 17
Failure to Prime 16
Infusion or Flow Problem 15
Failure to Align 13
Audible Prompt/Feedback Problem 12
Incomplete or Inadequate Connection 10
Material Twisted/Bent 10
Output Problem 10
Poor Quality Image 10
Detachment of Device or Device Component 9
Failure to Power Up 9
Firing Problem 9

Yearly Trend

18
2018: 14
19
2019: 70
20
2020: 85
21
2021: 99
22
2022: 174
23
2023: 254
24
2024: 309
25
2025: 291
26
2026: 153

Reports in 2025 (291) held close to the prior two-year average of 282.

Related Entities for Fluid Jet Removal System

Event Locations

1,221 (84.3%)
I 209 (14.4%)
HOSPITAL 19 (1.3%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Fluid Jet Removal System: 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 (1,449 here).

Similar death-typed counts

Nearest other device types by death-typed report count (35 here), distinct from the volume row.

Disclaimer: MAUDE figures for Fluid Jet Removal System 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 Fluid Jet Removal System; 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.