2026 data FDA MAUDE openFDA FDA Class II

Light, Surgical, 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 §878.4580 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Light, Surgical, Accessories LIGHT-BOOK · MAUDE

#995 of 1000 · 369 reports · 1992–2026

  • BOOK 369 reports
  • RANK #995 of 1000
  • DEATH 0 death-typed
  • INJ 12 injury-typed
  • MALF 355 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 105
  • PHOTO Material, Impression

Nearest event-volume peer: Material, Impression (0 report gap)

Light, Surgical, Accessories sits #995 of 1000 among tracked device types with 369 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 →

Malfunction reports run above the device-type norm

Light, Surgical, Accessories carries 96.2% MALFUNCTION-coded reports, 31.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 3.3% corpus 30.3% · below corpus mean (-27.0 pp)
  • MALF 96.2% corpus 64.8% · above corpus mean (+31.4 pp)

Lead product-problem code Detachment of Device or Device Component is 34% of coded problems · Lead manufacturer MAQUET SAS accounts for 100% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Light, Surgical, Accessories in the event-volume neighbourhood

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

reports

What this shows Light, Surgical, Accessories carries 369 MAUDE reports, ranked #995 of 1000.

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

Event Types

Malfunction 355 (96.2%)
Injury 12 (3.3%)
1 (0.3%)
Other 1 (0.3%)

Patient Outcomes

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

330 (89.7%)
Other 29 (7.9%)
Required Intervention 4 (1.1%)
R 3 (0.8%)
Hospitalization 2 (0.5%)

Top Product Problems

Detachment of Device or Device Component 122
Crack 44
Component Falling 30
Display or Visual Feedback Problem 26
Device Fell 25
Unsealed Device Packaging 17
Contamination 13
Fitting Problem 12
Break 11
Loose 10
Split 9
Material Puncture/Hole 7
Detachment Of Device Component 6
Device Operates Differently Than Expected 5
Device Packaging Compromised 5
Contamination /Decontamination Problem 4
Device Dislodged or Dislocated 4
Loose or Intermittent Connection 4
Material Integrity Problem 4
Packaging Problem 4

Yearly Trend

92
1992: 1
99
1999: 9
00
2000: 3
09
2009: 3
13
2013: 18
14
2014: 7
15
2015: 15
16
2016: 15
17
2017: 22
18
2018: 21
19
2019: 20
20
2020: 18
21
2021: 20
22
2022: 14
23
2023: 105
24
2024: 29
25
2025: 19
26
2026: 30

Reports fell to 19 in 2025, down from an average of 67 in the two years before.

Related Entities for Light, Surgical, Accessories

Top Manufacturers

Event Locations

222 (60.2%)
I 100 (27.1%)
HOSPITAL 43 (11.7%)
NO INFORMATION 3 (0.8%)
INVALID DATA 1 (0.3%)

Nationwide devices with a comparable report-volume footprint

Light, Surgical, Accessories carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (369 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Light, Surgical, 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 Light, Surgical, 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.