Hemostatic Device For Endoscopic Gastrointestinal Use
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 §878.4456 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Hemostatic Device For Endoscopic Gastrointe… LIGHT-BOOK · MAUDE
#647 of 1000 · 1,077 reports · 2018–2026
- BOOK 1,077 reports
- RANK #647 of 1000
- DEATH 9 death-typed
- INJ 160 injury-typed
- MALF 908 malfunction
- SPAN 2018–2026
- PEAK 2019: 218
- PHOTO Introducer
Nearest event-volume peer: Introducer, Syringe Needle (2 report gap)
Hemostatic Device For Endoscopic Gastrointestinal Use sits #647 of 1000 among tracked device types with 1,077 MAUDE reports spanning 2018–2026. 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
Hemostatic Device For Endoscopic Gastrointe… carries 84.3% MALFUNCTION-coded reports, 19.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
- INJ 14.9% corpus 30.3% · below corpus mean (-15.4 pp)
- MALF 84.3% corpus 64.8% · above corpus mean (+19.5 pp)
Lead product-problem code Activation Failure is 40% of coded problems · Lead manufacturer WILSON-COOK MEDICAL INC accounts for 53% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .
Hemostatic Device For Endoscopic Gastrointe… in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Automated Uri…
Automated Urinalysis System
1,086 reports
- Introducer
Introducer, Syringe Needle
1,079 reports
- Hemostatic De… (this)
Hemostatic Device For Endoscopic Gastrointestinal Use
1,077 reports
- System
System, Dialysate Delivery, Single Patient
1,072 reports
- Occluder
Occluder, Patent Ductus, Arteriosus
1,071 reports
- Catheter
Catheter, Oximeter, Fiber-Optic
1,067 reports
What this shows Hemostatic Device For Endoscopic Gastrointestinal Use carries 1,077 MAUDE reports, ranked #647 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 in 2025 (126) held close to the prior two-year average of 143.
Related Entities for Hemostatic Device For Endoscopic Gastrointestinal Use
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Hemostatic Device For Endoscopic Gastrointe…: 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 (1,077 here).
Similar death-typed counts
Nearest other device types by death-typed report count (9 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Hemostatic Device For Endoscopic Gastrointe… 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 Hemostatic Device For Endoscopic Gastrointe…; 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.