2026 data FDA MAUDE openFDA FDA Class II

Pump, Air, Non-Manual, For Endoscope

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 §876.1500 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Pump, Air, Non-Manual, For Endoscope LIGHT-BOOK · MAUDE

#600 of 1000 · 1,316 reports · 1995–2026

  • BOOK 1,316 reports
  • RANK #600 of 1000
  • DEATH 2 death-typed
  • INJ 20 injury-typed
  • MALF 1,288 malfunction
  • SPAN 1995–2026
  • PEAK 2024: 705
  • PHOTO Disinfector

Nearest event-volume peer: Disinfector, Medical Devices (1 report gap)

Pump, Air, Non-Manual, For Endoscope sits #600 of 1000 among tracked device types with 1,316 MAUDE reports spanning 1995–2026. 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

Pump, Air, Non-Manual, For Endoscope carries 97.9% MALFUNCTION-coded reports, 33.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 1.5% corpus 30.3% · below corpus mean (-28.8 pp)
  • MALF 97.9% corpus 64.8% · above corpus mean (+33.0 pp)

Lead product-problem code Pumping Problem is 21% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 43% of manufacturer-tagged reports · Top event location is 95% of location-tagged rows .

Pump, Air, Non-Manual, For Endoscope in the event-volume neighbourhood

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

reports

What this shows Pump, Air, Non-Manual, For Endoscope carries 1,316 MAUDE reports, ranked #600 of 1000.

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

Event Types

Malfunction 1,288 (97.9%)
Injury 20 (1.5%)
3 (0.2%)
Other 3 (0.2%)
Death 2 (0.2%)

Patient Outcomes

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

1,281 (97.2%)
Other 23 (1.7%)
Required Intervention 5 (0.4%)
R 3 (0.2%)
O 2 (0.2%)
Hospitalization 2 (0.2%)
H 1 (0.1%)
Death 1 (0.1%)

Top Product Problems

Pumping Problem 231
Break 135
Key or Button Unresponsive/not Working 125
Leak/Splash 104
Infusion or Flow Problem 83
Failure to Pump 71
Improper Flow or Infusion 40
Insufficient Flow or Under Infusion 35
Crack 32
Mechanical Problem 31
Excess Flow or Over-Infusion 25
Loose or Intermittent Connection 24
Pressure Problem 24
Connection Problem 21
Free or Unrestricted Flow 21
Reflux within Device 21
Detachment of Device or Device Component 20
Electrical /Electronic Property Problem 20
Fluid/Blood Leak 20
Flushing Problem 19

Yearly Trend

95
1995: 1
00
2000: 2
05
2005: 1
08
2008: 1
09
2009: 1
11
2011: 1
12
2012: 2
13
2013: 4
15
2015: 1
16
2016: 1
17
2017: 4
18
2018: 22
19
2019: 6
20
2020: 5
21
2021: 3
22
2022: 19
23
2023: 11
24
2024: 705
25
2025: 344
26
2026: 182

Reports in 2025 (344) held close to the prior two-year average of 358.

Related Entities for Pump, Air, Non-Manual, For Endoscope

Event Locations

1,248 (94.8%)
I 37 (2.8%)
HOSPITAL 25 (1.9%)
OUTPATIENT TREATMENT FACILITY 3 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
INVALID DATA 1 (0.1%)
NO INFORMATION 1 (0.1%)

Compare BOSTON SCIENTIFIC CORPORATION vs SMITH & NEPHEW, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pump, Air, Non-Manual, For Endoscope: 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 (1,316 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Pump, Air, Non-Manual, For Endoscope 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 Pump, Air, Non-Manual, For Endoscope; 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.