PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §876.1500 (Gastroenterology, Urology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Insufflator LIGHT-BOOK · MAUDE

#865 of 1000 · 540 reports · 1993–2026

  • BOOK 540 reports
  • RANK #865 of 1000
  • DEATH 6 death-typed
  • INJ 125 injury-typed
  • MALF 379 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 146
  • PHOTO Bag

Nearest event-volume peer: Bag, Urinary, Ileostomy (1 report gap)

Insufflator, Automatic Carbon-Dioxide For Endoscope sits #865 of 1000 among tracked device types with 540 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 →

Injury-coded reports sit below the device-type norm

Insufflator carries 23.1% INJURY-coded reports, 7.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 23.1% corpus 30.3% · below corpus mean (-7.1 pp)
  • MALF 70.2% corpus 64.8% · above corpus mean (+5.4 pp)

Lead product-problem code Insufficient Device Problem Information is 17% of coded problems · Lead manufacturer KARL STORZ SE & CO. KG accounts for 84% of manufacturer-tagged reports · Top event location is 80% 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 540 MAUDE reports, ranked #865 of 1000.

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

Event Types

Malfunction 379 (70.2%)
Injury 125 (23.1%)
21 (3.9%)
Other 9 (1.7%)
Death 6 (1.1%)

Patient Outcomes

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

353 (62.0%)
Other 97 (17.0%)
Hospitalization 43 (7.6%)
Required Intervention 26 (4.6%)
R 12 (2.1%)
O 10 (1.8%)
H 6 (1.1%)
Life Threatening 6 (1.1%)
Death 5 (0.9%)
S 3 (0.5%)
L 2 (0.4%)
Disability 2 (0.4%)
Invalid Data 2 (0.4%)
D 1 (0.2%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Insufficient Device Problem Information 86
Defective Component 45
No Apparent Adverse Event 44
Gas Output Problem 43
Output Problem 40
Pressure Problem 34
Electrical /Electronic Property Problem 28
Adverse Event Without Identified Device or Use Problem 26
Unexpected Shutdown 25
Device Alarm System 18
Inflation Problem 15
Increase in Pressure 14
Pumping Stopped 14
Device Handling Problem 13
Device Operates Differently Than Expected 13
Infusion or Flow Problem 11
Gas/Air Leak 10
Replace 9
Unknown (for use when the device problem is not known) 9
Use of Device Problem 9

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: 90

Reports rose to 146 in 2025, up from an average of 45 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Insufflator, Automatic Carbon-Dioxide For Endoscope

Top Manufacturers

KARL STORZ SE & CO. KG 319
STRYKER ENDOSCOPY SAN JOSE 36
SHIRAKAWA OLYMPUS CO., LTD. 18
OLYMPUS MEDICAL SYSTEMS CORP. 9

Event Locations

433 (80.2%)
HOSPITAL 75 (13.9%)
I 25 (4.6%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Insufflator: 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 (540 here).

Bag, Urinary, Ileostomy 539 Container, Specimen, Sterile 539 Insufflator, Hysteroscopic 541 Accessories, Pump, Infusion 537

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 Dilator, Catheter, Ureteral 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.