System, Irrigation, Urological
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 §876.5130 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book System, Irrigation, Urological LIGHT-BOOK · MAUDE
#641 of 1000 · 1,103 reports · 1993–2026
- BOOK 1,103 reports
- RANK #641 of 1000
- DEATH 2 death-typed
- INJ 9 injury-typed
- MALF 1,086 malfunction
- SPAN 1993–2026
- PEAK 2015: 642
- PHOTO Laryngoscope
Nearest event-volume peer: Laryngoscope, Non-Rigid (4 report gap)
System, Irrigation, Urological sits #641 of 1000 among tracked device types with 1,103 MAUDE reports spanning 1993–2026. 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
System, Irrigation, Urological carries 98.5% MALFUNCTION-coded reports, 33.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 0.8% corpus 30.3% · below corpus mean (-29.5 pp)
- MALF 98.5% corpus 64.8% · above corpus mean (+33.6 pp)
Lead product-problem code Material Integrity Problem is 52% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 32% of manufacturer-tagged reports · Top event location is 83% of location-tagged rows .
System, Irrigation, Urological in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Intervertebra…
Intervertebral Fusion Device With Bone Graft, Cervical
1,117 reports
- Dilator
Dilator, Catheter, Ureteral
1,108 reports
- System (this)
System, Irrigation, Urological
1,103 reports
- Laryngoscope
Laryngoscope, Non-Rigid
1,099 reports
- Growing Rod S…
Growing Rod System- Magnetic Actuation
1,094 reports
- Instrument
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
1,087 reports
What this shows System, Irrigation, Urological carries 1,103 MAUDE reports, ranked #641 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 (25) held close to the prior two-year average of 24.
Related Entities for System, Irrigation, Urological
Top Manufacturers
Event Locations
Compare BAXTER HEALTHCARE CORPORATION vs BAXTER HEALTHCARE →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for System, Irrigation, Urological: 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 (1,103 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for System, Irrigation, Urological 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 System, Irrigation, Urological; 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.