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2026 data FDA MAUDE openFDA FDA Class II

System, Gastrointestinal Motility (Electrical)

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 §876.1725 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book System, Gastrointestinal Motility LIGHT-BOOK · MAUDE

#953 of 1000 · 417 reports · 1999–2026

  • BOOK 417 reports
  • RANK #953 of 1000
  • DEATH 0 death-typed
  • INJ 77 injury-typed
  • MALF 332 malfunction
  • SPAN 1999–2026
  • PEAK 2026: 90
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Carotid Sinus Nerve (1 report gap)

System, Gastrointestinal Motility (Electrical) sits #953 of 1000 among tracked device types with 417 MAUDE reports spanning 1999–2026. 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

System, Gastrointestinal Motility carries 79.6% MALFUNCTION-coded reports, 14.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 18.5% corpus 30.3% · below corpus mean (-11.8 pp)
  • MALF 79.6% corpus 64.8% · above corpus mean (+14.8 pp)

Lead product-problem code Difficult to Remove is 34% of coded problems · Lead manufacturer COVIDIEN LP accounts for 71% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

System, Gastrointestinal Motility in the event-volume neighbourhood

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

reports

What this shows System, Gastrointestinal Motility (Electrical) carries 417 MAUDE reports, ranked #953 of 1000.

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

Event Types

Malfunction 332 (79.6%)
Injury 77 (18.5%)
5 (1.2%)
Other 3 (0.7%)

Patient Outcomes

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

304 (71.4%)
Required Intervention 50 (11.7%)
Other 44 (10.3%)
R 11 (2.6%)
Hospitalization 8 (1.9%)
O 5 (1.2%)
Life Threatening 2 (0.5%)
H 1 (0.2%)
Death 1 (0.2%)

Top Product Problems

Difficult to Remove 113
Manufacturing, Packaging or Shipping Problem 51
Insufficient Device Problem Information 22
Material Integrity Problem 18
Adverse Event Without Identified Device or Use Problem 17
Material Deformation 13
Therapeutic or Diagnostic Output Failure 11
Contamination /Decontamination Problem 9
Device Operates Differently Than Expected 9
Break 8
Failure of Device to Self-Test 8
Failure to Calibrate 8
Device Displays Incorrect Message 7
Application Program Freezes or Fails to Launch 6
Decrease in Pressure 6
Patient-Device Incompatibility 6
Device Damaged Prior to Use 5
Device Difficult to Program or Calibrate 5
Loss of Data 5
Detachment of Device or Device Component 4

Yearly Trend

99
1999: 1
04
2004: 2
09
2009: 2
10
2010: 6
11
2011: 6
12
2012: 4
13
2013: 4
14
2014: 4
15
2015: 10
16
2016: 15
17
2017: 10
18
2018: 17
19
2019: 27
20
2020: 20
21
2021: 26
22
2022: 31
23
2023: 51
24
2024: 59
25
2025: 32
26
2026: 90

Reports fell to 32 in 2025, down from an average of 55 in the two years before.

Related Entities for System, Gastrointestinal Motility (Electrical)

Top Manufacturers

COVIDIEN LP 47
COVIDIEN 19

Event Locations

212 (50.8%)
HOSPITAL 104 (24.9%)
I 83 (19.9%)
NO INFORMATION 5 (1.2%)
OUTPATIENT TREATMENT FACILITY 5 (1.2%)
OTHER 4 (1.0%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (1.0%)

Compare COVIDIEN LP vs COVIDIEN →

Nationwide devices with a comparable report-volume footprint

System, Gastrointestinal Motility carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (417 here).

Stimulator, Carotid Sinus Nerve 416 Table, Radiologic 418 Fibrin Sealant Preparation Device 419 Burr, Orthopedic 414

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for System, Gastrointestinal Motility 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, Gastrointestinal Motility; 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.