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 Class II (moderate risk, special controls required), regulated under 21 CFR §876.1500 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Endoscopic Tissue Approximation Device LIGHT-BOOK · MAUDE
#394 of 1000 · 3,154 reports · 2004–2026
- BOOK 3,154 reports
- RANK #394 of 1000
- DEATH 15 death-typed
- INJ 858 injury-typed
- MALF 2,266 malfunction
- SPAN 2004–2026
- PEAK 2017: 420
- PHOTO Dilator
Nearest event-volume peer: Dilator, Vessel, For Percutaneous Catheterization (2 report gap)
Endoscopic Tissue Approximation Device sits #394 of 1000 among tracked device types with 3,154 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 →
Malfunction reports run above the device-type norm
Endoscopic Tissue Approximation Device carries 71.8% MALFUNCTION-coded reports, 7.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
- INJ 27.2% corpus 30.3% · below corpus mean (-3.1 pp)
- MALF 71.8% corpus 64.8% · above corpus mean (+7.0 pp)
Lead product-problem code Break is 24% of coded problems · Lead manufacturer DAVIS & GECK CARIBE LTD accounts for 71% of manufacturer-tagged reports · Top event location 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
- Apparatus
Apparatus, Autotransfusion
3,163 reports
- Dilator
Dilator, Vessel, For Percutaneous Catheterization
3,156 reports
- Endoscopic Ti… (this)
Endoscopic Tissue Approximation Device
3,154 reports
- Saline
Saline, Vascular Access Flush
3,148 reports
- Dressing
Dressing, Wound, Drug
3,144 reports
- Culture Media
Culture Media, Enriched
3,141 reports
What this shows Endoscopic Tissue Approximation Device carries 3,154 MAUDE reports, ranked #394 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 329 in 2025, up from an average of 219 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Endoscopic Tissue Approximation Device
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Endoscopic Tissue Approximation Device: 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 (3,154 here).
Similar death-typed counts
Nearest other device types by death-typed report count (15 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.