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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book System LIGHT-BOOK · MAUDE

#763 of 1000 · 692 reports · 2002–2026

  • BOOK 692 reports
  • RANK #763 of 1000
  • DEATH 24 death-typed
  • INJ 412 injury-typed
  • MALF 242 malfunction
  • SPAN 2002–2026
  • PEAK 2024: 103
  • PHOTO Implanted Brain Stimu…

Nearest event-volume peer: Implanted Brain Stimulator For Epilepsy (1 report gap)

System, Imaging, Gastrointestinal, Wireless, Capsule sits #763 of 1000 among tracked device types with 692 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 →

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 3.5% corpus 1.5% · above corpus mean (+1.9 pp)
  • INJ 59.5% corpus 30.4% · above corpus mean (+29.1 pp)
  • MALF 35.0% corpus 64.5% · below corpus mean (-29.5 pp)

Lead product-problem code Entrapment of Device is 34% of coded problems · Lead manufacturer GIVEN IMAGING LTD., YOQNEAM accounts for 66% of manufacturer-tagged reports · Top event location is 49% 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 692 MAUDE reports, ranked #763 of 1000.

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

Event Types

Injury 412 (59.5%)
Malfunction 242 (35.0%)
Death 24 (3.5%)
8 (1.2%)
Other 6 (0.9%)

Patient Outcomes

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

239 (30.3%)
Required Intervention 231 (29.2%)
Other 130 (16.5%)
Hospitalization 62 (7.8%)
R 61 (7.7%)
Death 24 (3.0%)
O 22 (2.8%)
H 10 (1.3%)
L 5 (0.6%)
S 3 (0.4%)
Disability 2 (0.3%)
Life Threatening 1 (0.1%)

Top Product Problems

Entrapment of Device 182
Adverse Event Without Identified Device or Use Problem 136
Output Problem 25
Insufficient Information 24
Human-Device Interface Problem 20
Unintended Application Program Shut Down 19
Device Operates Differently Than Expected 17
Failure to Transmit Record 13
Communication or Transmission Problem 12
Detachment of Device or Device Component 12
Break 11
Positioning Problem 10
Loss of Power 8
Material Fragmentation 7
Patient-Device Incompatibility 7
Activation, Positioning or Separation Problem 6
Data Problem 6
Defective Device 6
Difficult to Remove 6
No Display/Image 6

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: 8

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

Top Manufacturers

GIVEN IMAGING LTD., YOQNEAM 245
GIVEN IMAGING LTD. 53
GIVEN IMAGING LTD 42
SHIRAKAWA OLYMPUS CO., LTD. 30

Event Locations

342 (49.4%)
I 267 (38.6%)
HOSPITAL 55 (7.9%)
NO INFORMATION 10 (1.4%)
OUTPATIENT DIAGNOSTIC FACILITY 9 (1.3%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for System, 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 (692 here).

Implanted Brain Stimulator For Epilepsy 693 Resin, Root Canal Filling 693 Single Analyte Controls 694 Radioimmunoassay, Estradiol 689

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.