2026 data FDA MAUDE openFDA FDA Class II

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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 §880.6740 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Apparatus LIGHT-BOOK · MAUDE

#532 of 1000 · 1,734 reports · 1992–2026

  • BOOK 1,734 reports
  • RANK #532 of 1000
  • DEATH 21 death-typed
  • INJ 104 injury-typed
  • MALF 1,572 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 280
  • PHOTO Transmitters And Rece…

Nearest event-volume peer: Transmitters And Receivers, Physiological Signal, Radiofrequency (20 report gap)

Apparatus, Suction, Operating-Room, Wall Vacuum Powered sits #532 of 1000 among tracked device types with 1,734 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

Apparatus carries 90.7% MALFUNCTION-coded reports, 25.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 6.0% corpus 30.3% · below corpus mean (-24.3 pp)
  • MALF 90.7% corpus 64.8% · above corpus mean (+25.8 pp)

Lead product-problem code Suction Problem is 23% of coded problems · Lead manufacturer STRYKER ENDOSCOPY-SAN JOSE accounts for 79% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Apparatus in the event-volume neighbourhood

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

reports

What this shows Apparatus, Suction, Operating-Room, Wall Vacuum Powered carries 1,734 MAUDE reports, ranked #532 of 1000.

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

Event Types

Malfunction 1,572 (90.7%)
Injury 104 (6.0%)
Death 21 (1.2%)
19 (1.1%)
Other 18 (1.0%)

Patient Outcomes

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

1,447 (83.6%)
Other 154 (8.9%)
Required Intervention 67 (3.9%)
Death 20 (1.2%)
Hospitalization 16 (0.9%)
Life Threatening 7 (0.4%)
R 6 (0.3%)
L 5 (0.3%)
O 3 (0.2%)
Invalid Data 2 (0.1%)
D 1 (0.1%)
H 1 (0.1%)
S 1 (0.1%)

Top Product Problems

Suction Problem 342
Device Contamination with Chemical or Other Material 132
Fluid/Blood Leak 117
Leak/Splash 89
Smoking 78
Break 76
Delivered as Unsterile Product 71
Device Contaminated During Manufacture or Shipping 64
Replace 58
Crack 57
Decrease in Pressure 55
Vacuum, loss of 52
Overheating of Device 46
Sticking 43
Detachment of Device or Device Component 42
Suction Failure 42
Temperature Problem 40
Packaging Problem 35
Material Fragmentation 32
Mechanical Problem 32

Yearly Trend

92
1992: 13
93
1993: 5
94
1994: 2
95
1995: 2
96
1996: 3
97
1997: 6
98
1998: 4
99
1999: 2
00
2000: 4
01
2001: 6
02
2002: 83
03
2003: 26
04
2004: 9
05
2005: 13
06
2006: 11
07
2007: 24
08
2008: 44
09
2009: 40
10
2010: 51
11
2011: 67
12
2012: 242
13
2013: 47
14
2014: 32
15
2015: 52
16
2016: 99
17
2017: 45
18
2018: 50
19
2019: 65
20
2020: 65
21
2021: 65
22
2022: 72
23
2023: 59
24
2024: 65
25
2025: 280
26
2026: 81

Reports rose to 280 in 2025, up from an average of 62 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Event Locations

1,094 (63.1%)
I 349 (20.1%)
HOSPITAL 255 (14.7%)
NO INFORMATION 16 (0.9%)
UNKNOWN 5 (0.3%)
INVALID DATA 3 (0.2%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
HOME 2 (0.1%)
NOT APPLICABLE 2 (0.1%)
OTHER 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)

Compare STRYKER ENDOSCOPY-SAN JOSE vs CARDINAL HEALTH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Apparatus: 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 (1,734 here).

Similar death-typed counts

Nearest other device types by death-typed report count (21 here), distinct from the volume row.

Disclaimer: MAUDE figures for Apparatus 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; 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.