2026 data FDA MAUDE openFDA

Endoscopic Tissue Approximation Device

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 MAUDE casebook

openFDA event book Endoscopic Tissue Approximation Device LIGHT-BOOK · MAUDE

#408 of 1000 · 2,878 reports · 2004–2026

  • BOOK 2,878 reports
  • RANK #408 of 1000
  • DEATH 14 death-typed
  • INJ 746 injury-typed
  • MALF 2,103 malfunction
  • SPAN 2004–2026
  • PEAK 2017: 420
  • PHOTO Light Source

Nearest event-volume peer: Light Source, Fiberoptic, Routine (7 report gap)

Endoscopic Tissue Approximation Device sits #408 of 1000 among tracked device types with 2,878 MAUDE reports spanning 2004–2026. 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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 25.9% corpus 30.4% · below corpus mean (-4.5 pp)
  • MALF 73.1% corpus 64.5% · above corpus mean (+8.6 pp)

Lead product-problem code Break is 24% of coded problems · Lead manufacturer DAVIS & GECK CARIBE LTD accounts for 76% of manufacturer-tagged reports · Top event location I is 46% of location-tagged rows .

Endoscopic Tissue Approximation Device in the event-volume neighbourhood

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

reports

What this shows Endoscopic Tissue Approximation Device carries 2,878 MAUDE reports, ranked #408 of 1000.

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

Event Types

Malfunction 2,103 (73.1%)
Injury 746 (25.9%)
Death 14 (0.5%)
12 (0.4%)
Other 3 (0.1%)

Patient Outcomes

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

1,986 (64.9%)
Required Intervention 477 (15.6%)
Other 304 (9.9%)
R 108 (3.5%)
Hospitalization 80 (2.6%)
O 50 (1.6%)
H 15 (0.5%)
Death 14 (0.5%)
Life Threatening 9 (0.3%)
L 5 (0.2%)
Disability 5 (0.2%)
S 4 (0.1%)
D 2 (0.1%)

Top Product Problems

Break 889
Detachment of Device or Device Component 820
Human-Device Interface Problem 578
Detachment Of Device Component 389
Adverse Event Without Identified Device or Use Problem 193
Component or Accessory Incompatibility 181
Difficult to Open or Close 116
Entrapment of Device 72
Mechanical Jam 58
Material Twisted/Bent 54
Mechanical Problem 50
Device-Device Incompatibility 49
Difficult to Remove 49
Insufficient Information 45
Failure to Align 39
Activation Failure 33
Physical Resistance/Sticking 32
Device Operates Differently Than Expected 30
Defective Device 23
Misfire 22

Yearly Trend

04
2004: 5
05
2005: 1
06
2006: 1
07
2007: 9
08
2008: 47
09
2009: 30
10
2010: 10
11
2011: 16
12
2012: 28
13
2013: 2
14
2014: 28
15
2015: 59
16
2016: 74
17
2017: 420
18
2018: 413
19
2019: 291
20
2020: 183
21
2021: 198
22
2022: 235
23
2023: 227
24
2024: 211
25
2025: 329
26
2026: 61

Related Entities for Endoscopic Tissue Approximation Device

Event Locations

I 1,313 (45.6%)
1,168 (40.6%)
HOSPITAL 243 (8.4%)
OTHER 85 (3.0%)
NO INFORMATION 67 (2.3%)
NOT APPLICABLE 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare DAVIS & GECK CARIBE LTD vs COVIDIEN →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Endoscopic Tissue Approximation Device, 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 (2,878 here).

Similar death-typed counts

Nearest other device types by death-typed report count (14 here), distinct from the volume row.

Disclaimer: MAUDE figures for Endoscopic Tissue Approximation Device 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 Endoscopic Tissue Approximation Device; 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.