2026 data FDA MAUDE openFDA FDA Class I

Electrode, Ph, Stomach

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §876.1400 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Electrode, Ph, Stomach MID-BOOK · MAUDE

#189 of 1000 · 12,853 reports · 1992–2026

  • BOOK 12,853 reports
  • RANK #189 of 1000
  • DEATH 9 death-typed
  • INJ 952 injury-typed
  • MALF 11,838 malfunction
  • SPAN 1992–2026
  • PEAK 2012: 1,707
  • PHOTO Shoulder Prosthesis

Nearest event-volume peer: Shoulder Prosthesis, Reverse Configuration (82 report gap)

Electrode, Ph, Stomach sits #189 of 1000 among tracked device types with 12,853 MAUDE reports spanning 1992–2026. 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

Electrode, Ph, Stomach carries 92.1% MALFUNCTION-coded reports, 27.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 7.4% corpus 30.3% · below corpus mean (-22.9 pp)
  • MALF 92.1% corpus 64.8% · above corpus mean (+27.3 pp)

Lead product-problem code Failure To Adhere Or Bond is 42% of coded problems · Lead manufacturer GIVEN IMAGING LTD., YOQNEAM accounts for 49% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Electrode, Ph, Stomach in the event-volume neighbourhood

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

reports

What this shows Electrode, Ph, Stomach carries 12,853 MAUDE reports, ranked #189 of 1000.

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

Event Types

Malfunction 11,838 (92.1%)
Injury 952 (7.4%)
30 (0.2%)
Other 24 (0.2%)
Death 9 (0.1%)

Patient Outcomes

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

6,888 (53.2%)
Required Intervention 5,595 (43.2%)
Other 258 (2.0%)
R 71 (0.5%)
Hospitalization 63 (0.5%)
O 29 (0.2%)
Disability 15 (0.1%)
H 9 (0.1%)
Death 7 (0.1%)
Life Threatening 7 (0.1%)
L 4 (0.0%)
S 1 (0.0%)

Top Product Problems

Failure To Adhere Or Bond 5,766
Positioning Failure 3,588
Loss of or Failure to Bond 861
Other (for use when an appropriate device code cannot be identified) 612
Separation Failure 599
Detachment Of Device Component 482
Device Operates Differently Than Expected 263
Detachment of Device or Device Component 249
Failure to Transmit Record 214
Migration or Expulsion of Device 180
Communication or Transmission Problem 168
Entrapment of Device 133
Handpiece break 125
Adverse Event Without Identified Device or Use Problem 104
Insufficient Device Problem Information 96
Break 86
Failure to Advance 82
Connection Problem 80
Device Slipped 80
Unknown (for use when the device problem is not known) 74

Yearly Trend

92
1992: 1
94
1994: 1
96
1996: 1
97
1997: 3
99
1999: 5
00
2000: 1
01
2001: 2
03
2003: 21
04
2004: 7
05
2005: 20
06
2006: 20
07
2007: 499
08
2008: 884
09
2009: 336
10
2010: 928
11
2011: 1,506
12
2012: 1,707
13
2013: 314
14
2014: 306
15
2015: 347
16
2016: 472
17
2017: 896
18
2018: 955
19
2019: 621
20
2020: 770
21
2021: 516
22
2022: 260
23
2023: 259
24
2024: 239
25
2025: 594
26
2026: 362

Reports rose to 594 in 2025, up from an average of 249 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Electrode, Ph, Stomach

Event Locations

6,311 (49.1%)
I 4,743 (36.9%)
OTHER 1,326 (10.3%)
HOSPITAL 228 (1.8%)
NOT APPLICABLE 108 (0.8%)
NO INFORMATION 80 (0.6%)
OUTPATIENT DIAGNOSTIC FACILITY 21 (0.2%)
AMBULATORY SURGICAL FACILITY 10 (0.1%)
UNKNOWN 10 (0.1%)
OUTPATIENT TREATMENT FACILITY 9 (0.1%)
HOME 7 (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 Electrode, Ph, Stomach: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Disclaimer: MAUDE figures for Electrode, Ph, Stomach 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 Electrode, Ph, Stomach; 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.