PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Tube, Gastro-Enterostomy

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 §876.5980 (Gastroenterology, Urology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Tube, Gastro-Enterostomy LIGHT-BOOK · MAUDE

#616 of 1000 · 1,228 reports · 1992–2026

  • BOOK 1,228 reports
  • RANK #616 of 1000
  • DEATH 18 death-typed
  • INJ 219 injury-typed
  • MALF 986 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 118
  • PHOTO System/Device

Nearest event-volume peer: System/Device, Pharmacy Compounding (2 report gap)

Tube, Gastro-Enterostomy sits #616 of 1000 among tracked device types with 1,228 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

Tube, Gastro-Enterostomy carries 80.3% MALFUNCTION-coded reports, 15.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.5% corpus 1.5% · near corpus mean (-0.0 pp)
  • INJ 17.8% corpus 30.3% · below corpus mean (-12.5 pp)
  • MALF 80.3% corpus 64.8% · above corpus mean (+15.5 pp)

Lead product-problem code Break is 50% of coded problems · Lead manufacturer AVANOS MEDICAL INC. accounts for 56% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Tube, Gastro-Enterostomy in the event-volume neighbourhood

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

reports

What this shows Tube, Gastro-Enterostomy carries 1,228 MAUDE reports, ranked #616 of 1000.

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

Event Types

Malfunction 986 (80.3%)
Injury 219 (17.8%)
Death 18 (1.5%)
3 (0.2%)
Other 2 (0.2%)

Patient Outcomes

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

904 (72.1%)
Other 160 (12.8%)
Required Intervention 118 (9.4%)
Hospitalization 23 (1.8%)
Death 16 (1.3%)
R 11 (0.9%)
O 7 (0.6%)
H 4 (0.3%)
D 3 (0.2%)
L 3 (0.2%)
Life Threatening 3 (0.2%)
Invalid Data 1 (0.1%)

Top Product Problems

Break 544
Detachment Of Device Component 99
Leak/Splash 52
Fluid/Blood Leak 50
Adverse Event Without Identified Device or Use Problem 48
Detachment of Device or Device Component 39
Fracture 36
Peeled/Delaminated 35
Migration or Expulsion of Device 23
Difficult to Remove 20
Burst Container or Vessel 19
Difficult to Advance 16
Migration 15
Appropriate Device Problem Term/Code Not Available 14
Occlusion Within Device 14
Unintended Movement 13
Device Dislodged or Dislocated 12
Improper or Incorrect Procedure or Method 12
Premature Separation 12
Material Rupture 11

Yearly Trend

92
1992: 6
93
1993: 1
94
1994: 1
95
1995: 2
96
1996: 1
97
1997: 7
98
1998: 1
99
1999: 1
00
2000: 4
03
2003: 1
04
2004: 1
05
2005: 5
06
2006: 7
07
2007: 12
08
2008: 30
09
2009: 47
10
2010: 67
11
2011: 36
12
2012: 16
13
2013: 17
14
2014: 41
15
2015: 72
16
2016: 69
17
2017: 102
18
2018: 84
19
2019: 90
20
2020: 118
21
2021: 73
22
2022: 51
23
2023: 36
24
2024: 87
25
2025: 107
26
2026: 35

Reports rose to 107 in 2025, up from an average of 62 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Tube, Gastro-Enterostomy

Top Manufacturers

AVANOS MEDICAL INC. 507
BOSTON SCIENTIFIC - SPENCER 162
BARD ACCESS SYSTEMS 95
BOSTON SCIENTIFIC CORPORATION 87
C.R. BARD, INC. (BASD) -3006260740 27
AVANOS MEDICAL, INC. 21

Event Locations

616 (50.2%)
I 478 (38.9%)
HOSPITAL 85 (6.9%)
HOME 31 (2.5%)
NO INFORMATION 9 (0.7%)
OTHER 7 (0.6%)
INVALID DATA 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare AVANOS MEDICAL INC. vs BOSTON SCIENTIFIC - SPENCER →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tube, Gastro-Enterostomy: 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 (1,228 here).

System/Device, Pharmacy Compounding 1,226 Cardiovascular Procedure Kit 1,221 Clamp 1,235 Accessories, Blood Circuit, Hemodialysis 1,220

Similar death-typed counts

Nearest other device types by death-typed report count (18 here), distinct from the volume row.

Adaptor 18 Agent, Occluding, Vascular, Permanent 18 Agents 18 Prosthesis 18

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

Disclaimer: MAUDE figures for Tube, Gastro-Enterostomy 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 Tube, Gastro-Enterostomy; 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.