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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book System, Irrigation, Urological LIGHT-BOOK · MAUDE

#633 of 1000 · 1,093 reports · 1993–2026

  • BOOK 1,093 reports
  • RANK #633 of 1000
  • DEATH 2 death-typed
  • INJ 9 injury-typed
  • MALF 1,076 malfunction
  • SPAN 1993–2026
  • PEAK 2015: 642
  • PHOTO Growing Rod System- M…

Nearest event-volume peer: Growing Rod System- Magnetic Actuation (1 report gap)

System, Irrigation, Urological sits #633 of 1000 among tracked device types with 1,093 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 →

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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 0.8% corpus 30.4% · below corpus mean (-29.6 pp)
  • MALF 98.4% corpus 64.5% · above corpus mean (+33.9 pp)

Lead product-problem code Fluid/Blood Leak is 35% of coded problems · Lead manufacturer BAXTER HEALTHCARE accounts for 31% 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

reports

What this shows System, Irrigation, Urological carries 1,093 MAUDE reports, ranked #633 of 1000.

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

Event Types

Malfunction 1,076 (98.4%)
Injury 9 (0.8%)
3 (0.3%)
Other 3 (0.3%)
Death 2 (0.2%)

Patient Outcomes

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

1,076 (98.4%)
Other 9 (0.8%)
Required Intervention 4 (0.4%)
Death 3 (0.3%)
O 1 (0.1%)
Hospitalization 1 (0.1%)

Top Product Problems

Fluid/Blood Leak 76
Device Contamination with Chemical or Other Material 29
Leak/Splash 12
Loose or Intermittent Connection 12
Detachment of Device or Device Component 11
Break 8
Disconnection 8
Device Operates Differently Than Expected 7
Free or Unrestricted Flow 7
No Flow 7
Tear, Rip or Hole in Device Packaging 6
Filling Problem 5
Improper Flow or Infusion 5
Backflow 4
Incomplete or Inadequate Connection 4
Unsealed Device Packaging 4
Component Missing 3
Defective Component 3
Defective Device 3
Device Packaging Compromised 3

Yearly Trend

93
1993: 1
94
1994: 2
95
1995: 1
96
1996: 1
97
1997: 2
98
1998: 1
99
1999: 1
00
2000: 1
08
2008: 1
10
2010: 30
11
2011: 27
12
2012: 22
13
2013: 44
14
2014: 96
15
2015: 642
16
2016: 32
17
2017: 19
18
2018: 18
19
2019: 16
20
2020: 23
21
2021: 15
22
2022: 21
23
2023: 34
24
2024: 13
25
2025: 25
26
2026: 5

Related Entities for System, Irrigation, Urological

Top Manufacturers

BAXTER HEALTHCARE 125
BAXTER HEALTHCARE CORPORATION 124
BAXTER HEALTHCARE - MALTA 66
STRYKER ENDOSCOPY-SAN JOSE 56
BAXTER HEALTHCARE - AIBONITO 23
B. BRAUN MEDICAL INC. 8

Event Locations

911 (83.3%)
I 152 (13.9%)
HOSPITAL 23 (2.1%)
NO INFORMATION 3 (0.3%)
OTHER 2 (0.2%)
INVALID DATA 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare BAXTER HEALTHCARE vs BAXTER HEALTHCARE CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Irrigation, Urological, 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 (1,093 here).

Growing Rod System- Magnetic Actuation 1,094 Light Adjustable Lens And Light Delivery De… 1,092 Prosthesis, Hip, Hemi-, Femoral, Metal Ball 1,092 Dilator, Catheter, Ureteral 1,095

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Analyzer, Chemistry Clinical Use 2 Bed, Pediatric Open Hospital 2

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.