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2026 data FDA MAUDE openFDA FDA Class II

Apparatus, Exhaust, Surgical

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 §878.5070 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Apparatus, Exhaust, Surgical LIGHT-BOOK · MAUDE

#770 of 1000 · 720 reports · 1996–2026

  • BOOK 720 reports
  • RANK #770 of 1000
  • DEATH 5 death-typed
  • INJ 32 injury-typed
  • MALF 678 malfunction
  • SPAN 1996–2026
  • PEAK 2011: 150
  • PHOTO Radioimmunoassay

Nearest event-volume peer: Radioimmunoassay, Estradiol (1 report gap)

Apparatus, Exhaust, Surgical sits #770 of 1000 among tracked device types with 720 MAUDE reports spanning 1996–2026. 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

Apparatus, Exhaust, Surgical carries 94.2% MALFUNCTION-coded reports, 29.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 4.4% corpus 30.3% · below corpus mean (-25.8 pp)
  • MALF 94.2% corpus 64.8% · above corpus mean (+29.3 pp)

Lead product-problem code Sparking is 11% of coded problems · Lead manufacturer STRYKER INSTRUMENTS KALAMAZOO accounts for 53% of manufacturer-tagged reports · Top event location is 89% of location-tagged rows .

Apparatus, Exhaust, Surgical in the event-volume neighbourhood

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

reports

What this shows Apparatus, Exhaust, Surgical carries 720 MAUDE reports, ranked #770 of 1000.

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

Event Types

Malfunction 678 (94.2%)
Injury 32 (4.4%)
Death 5 (0.7%)
Other 5 (0.7%)

Patient Outcomes

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

679 (93.3%)
Required Intervention 20 (2.7%)
Other 10 (1.4%)
R 5 (0.7%)
Death 5 (0.7%)
Hospitalization 5 (0.7%)
L 2 (0.3%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Sparking 71
Smoking 68
Difficult or Delayed Activation 62
Suction Problem 57
Melted 47
Electrical /Electronic Property Problem 45
Fluid/Blood Leak 45
Device Operates Differently Than Expected 32
Break 30
Overheating of Device 29
Thermal Decomposition of Device 26
Material Integrity Problem 21
Adverse Event Without Identified Device or Use Problem 19
Arcing 18
Cut In Material 14
Complete Blockage 11
Device Displays Incorrect Message 11
Device Inoperable 11
Noise, Audible 11
Appropriate Device Problem Term/Code Not Available 10

Yearly Trend

96
1996: 1
97
1997: 1
01
2001: 1
02
2002: 6
03
2003: 5
04
2004: 2
05
2005: 4
06
2006: 1
07
2007: 3
08
2008: 4
09
2009: 5
10
2010: 39
11
2011: 150
12
2012: 120
13
2013: 142
14
2014: 71
15
2015: 21
16
2016: 2
17
2017: 3
18
2018: 5
19
2019: 11
20
2020: 11
21
2021: 20
22
2022: 46
23
2023: 19
24
2024: 11
25
2025: 15
26
2026: 1

Reports in 2025 (15) held close to the prior two-year average of 15.

Related Entities for Apparatus, Exhaust, Surgical

Top Manufacturers

STRYKER INSTRUMENTS KALAMAZOO 288
STRYKER INSTRUMENTS-KALAMAZOO 229
COVIDIEN MFG DC BOULDER 17
STRYKER INSTRUMENTS, KALAMAZOO 10

Event Locations

641 (89.0%)
I 38 (5.3%)
HOSPITAL 34 (4.7%)
NO INFORMATION 3 (0.4%)
AMBULATORY SURGICAL FACILITY 2 (0.3%)
OTHER 2 (0.3%)

Compare STRYKER INSTRUMENTS KALAMAZOO vs STRYKER INSTRUMENTS-KALAMAZOO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Apparatus, Exhaust, Surgical: 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 (720 here).

Radioimmunoassay, Estradiol 719 Humidifier Nebulizer Kit 723 System 723 System, Communication, Powered 714

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Bit, Drill 5 Calculator/Data Processing Module 5

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

Disclaimer: MAUDE figures for Apparatus, Exhaust, Surgical 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 Apparatus, Exhaust, Surgical; 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.