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2026 data FDA MAUDE openFDA FDA Class II

System, Imaging, Gastrointestinal, Wireless, Capsule

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 §876.1300 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book System LIGHT-BOOK · MAUDE

#769 of 1000 · 723 reports · 2002–2026

  • BOOK 723 reports
  • RANK #769 of 1000
  • DEATH 24 death-typed
  • INJ 436 injury-typed
  • MALF 249 malfunction
  • SPAN 2002–2026
  • PEAK 2024: 103
  • PHOTO Humidifier Nebulizer…

Nearest event-volume peer: Humidifier Nebulizer Kit (0 report gap)

System, Imaging, Gastrointestinal, Wireless, Capsule sits #769 of 1000 among tracked device types with 723 MAUDE reports spanning 2002–2026. 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 sit below the device-type norm

System carries 34.4% MALFUNCTION-coded reports, 30.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.3% corpus 1.5% · above corpus mean (+1.8 pp)
  • INJ 60.3% corpus 30.3% · above corpus mean (+30.0 pp)
  • MALF 34.4% corpus 64.8% · below corpus mean (-30.4 pp)

Lead product-problem code Entrapment of Device is 33% of coded problems · Lead manufacturer GIVEN IMAGING LTD., YOQNEAM accounts for 68% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

System in the event-volume neighbourhood

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

reports

What this shows System, Imaging, Gastrointestinal, Wireless, Capsule carries 723 MAUDE reports, ranked #769 of 1000.

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

Event Types

Injury 436 (60.3%)
Malfunction 249 (34.4%)
Death 24 (3.3%)
8 (1.1%)
Other 6 (0.8%)

Patient Outcomes

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

Required Intervention 253 (30.9%)
243 (29.7%)
Other 133 (16.2%)
Hospitalization 62 (7.6%)
R 61 (7.4%)
Death 24 (2.9%)
O 22 (2.7%)
H 10 (1.2%)
L 5 (0.6%)
S 3 (0.4%)
Disability 2 (0.2%)
Life Threatening 1 (0.1%)

Top Product Problems

Entrapment of Device 210
Adverse Event Without Identified Device or Use Problem 150
Insufficient Device Problem Information 37
Device Operates Differently Than Expected 26
Output Problem 25
Human-Device Interface Problem 22
Unintended Application Program Shut Down 20
Failure to Transmit Record 16
Difficult to Remove 15
Positioning Problem 14
Break 13
Communication or Transmission Problem 13
Detachment of Device or Device Component 12
No Display/Image 10
Sticking 10
Failure to Advance 9
Appropriate Device Problem Term/Code Not Available 8
Data Problem 8
Loss of Power 8
Material Fragmentation 8

Yearly Trend

02
2002: 3
03
2003: 3
04
2004: 3
05
2005: 8
06
2006: 2
08
2008: 9
09
2009: 6
10
2010: 13
11
2011: 10
12
2012: 19
13
2013: 6
14
2014: 13
15
2015: 30
16
2016: 57
17
2017: 55
18
2018: 50
19
2019: 56
20
2020: 31
21
2021: 41
22
2022: 63
23
2023: 34
24
2024: 103
25
2025: 69
26
2026: 39

Reports in 2025 (69) held close to the prior two-year average of 69.

Related Entities for System, Imaging, Gastrointestinal, Wireless, Capsule

Top Manufacturers

GIVEN IMAGING LTD., YOQNEAM 260
GIVEN IMAGING LTD. 53
GIVEN IMAGING LTD 42
SHIRAKAWA OLYMPUS CO., LTD. 30

Event Locations

372 (51.5%)
I 267 (36.9%)
HOSPITAL 56 (7.7%)
NO INFORMATION 10 (1.4%)
OUTPATIENT DIAGNOSTIC FACILITY 9 (1.2%)
UNKNOWN 4 (0.6%)
OTHER 3 (0.4%)
HOME 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare GIVEN IMAGING LTD., YOQNEAM vs GIVEN IMAGING LTD. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System: 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 (723 here).

Humidifier Nebulizer Kit 723 Apparatus, Exhaust, Surgical 720 Radioimmunoassay, Estradiol 719 Carboxymethylcellulose Sodium Or Polyvinyl… 729

Similar death-typed counts

Nearest other device types by death-typed report count (24 here), distinct from the volume row.

Apparatus, Suction, Patient Care 24 Catheter, Oximeter, Fiber-Optic 24 Chair, Positioning, Electric 24 Laparoscope, Gynecologic 24

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

Disclaimer: MAUDE figures for System 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 System; 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.