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2026 data FDA MAUDE openFDA

Insufflator, Automatic Carbon-Dioxide 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.

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FDA MAUDE casebook

openFDA event book Insufflator LIGHT-BOOK · MAUDE

#900 of 1000 · 463 reports · 1993–2026

  • BOOK 463 reports
  • RANK #900 of 1000
  • DEATH 6 death-typed
  • INJ 108 injury-typed
  • MALF 319 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 146
  • PHOTO Connector, Airway

Nearest event-volume peer: Connector, Airway (Extension) (0 report gap)

Insufflator, Automatic Carbon-Dioxide For Endoscope sits #900 of 1000 among tracked device types with 463 MAUDE reports spanning 1993–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 23.3% corpus 30.4% · below corpus mean (-7.1 pp)
  • MALF 68.9% corpus 64.5% · above corpus mean (+4.4 pp)

Lead product-problem code Insufficient Information is 19% of coded problems · Lead manufacturer KARL STORZ SE & CO. KG accounts for 80% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .

Insufflator in the event-volume neighbourhood

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

reports

What this shows Insufflator, Automatic Carbon-Dioxide For Endoscope carries 463 MAUDE reports, ranked #900 of 1000.

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

Event Types

Malfunction 319 (68.9%)
Injury 108 (23.3%)
21 (4.5%)
Other 9 (1.9%)
Death 6 (1.3%)

Patient Outcomes

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

294 (59.5%)
Other 84 (17.0%)
Hospitalization 43 (8.7%)
Required Intervention 24 (4.9%)
R 11 (2.2%)
O 9 (1.8%)
H 6 (1.2%)
Life Threatening 6 (1.2%)
Death 5 (1.0%)
S 3 (0.6%)
Disability 3 (0.6%)
L 2 (0.4%)
Invalid Data 2 (0.4%)
D 1 (0.2%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Insufficient Information 65
Defective Component 37
Gas Output Problem 30
No Apparent Adverse Event 29
Pressure Problem 27
Output Problem 22
Electrical /Electronic Property Problem 21
Unexpected Shutdown 20
Adverse Event Without Identified Device or Use Problem 16
Pumping Stopped 14
Device Alarm System 12
Device Handling Problem 11
Use of Device Problem 8
Gas/Air Leak 7
Improper Flow or Infusion 6
Intermittent Loss of Power 6
Mechanical Problem 6
Device Reprocessing Problem 5
Complete Loss of Power 4
Detachment of Device or Device Component 4

Yearly Trend

93
1993: 1
94
1994: 3
95
1995: 3
96
1996: 6
97
1997: 6
98
1998: 6
99
1999: 1
00
2000: 3
01
2001: 1
04
2004: 3
05
2005: 1
06
2006: 16
07
2007: 5
08
2008: 11
09
2009: 8
10
2010: 20
11
2011: 14
12
2012: 13
13
2013: 19
14
2014: 10
15
2015: 5
16
2016: 4
17
2017: 3
18
2018: 7
19
2019: 4
20
2020: 1
21
2021: 12
22
2022: 29
23
2023: 54
24
2024: 35
25
2025: 146
26
2026: 13

Related Entities for Insufflator, Automatic Carbon-Dioxide For Endoscope

Top Manufacturers

KARL STORZ SE & CO. KG 249
STRYKER ENDOSCOPY SAN JOSE 36
SHIRAKAWA OLYMPUS CO., LTD. 17
OLYMPUS MEDICAL SYSTEMS CORP. 9

Event Locations

365 (78.8%)
HOSPITAL 66 (14.3%)
I 25 (5.4%)
INVALID DATA 3 (0.6%)
AMBULATORY SURGICAL FACILITY 2 (0.4%)
NO INFORMATION 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)

Compare KARL STORZ SE & CO. KG vs STRYKER ENDOSCOPY SAN JOSE →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Insufflator, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (463 here).

Connector, Airway 463 Urinometer, Electrical 463 Microscope, Surgical 465 Injector, Fluid, Non-Electrically Powered 467

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Device, Percutaneous Retrieval 6

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

Disclaimer: MAUDE figures for Insufflator 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 Insufflator; 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.