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2022 data FDA MAUDE openFDA FDA Class I

Table, Cystometric, Non-Electric And Accessories

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §876.4890 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Table LIGHT-BOOK · MAUDE

#808 of 1000 · 638 reports · 1994–2022

  • BOOK 638 reports
  • RANK #808 of 1000
  • DEATH 0 death-typed
  • INJ 5 injury-typed
  • MALF 624 malfunction
  • SPAN 1994–2022
  • PEAK 2009: 178
  • PHOTO Elevator

Nearest event-volume peer: Elevator, Surgical, Dental (0 report gap)

Table, Cystometric, Non-Electric And Accessories sits #808 of 1000 among tracked device types with 638 MAUDE reports spanning 1994–2022. 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

Table carries 97.8% MALFUNCTION-coded reports, 33.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.8% corpus 30.3% · below corpus mean (-29.5 pp)
  • MALF 97.8% corpus 64.8% · above corpus mean (+33.0 pp)

Lead product-problem code No Device Output is 42% of coded problems · Lead manufacturer COVIDIEN accounts for 100% of manufacturer-tagged reports · Top event location is 97% of location-tagged rows .

Table in the event-volume neighbourhood

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

reports

What this shows Table, Cystometric, Non-Electric And Accessories carries 638 MAUDE reports, ranked #808 of 1000.

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

Event Types

Malfunction 624 (97.8%)
Other 6 (0.9%)
Injury 5 (0.8%)
3 (0.5%)

Patient Outcomes

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

619 (96.9%)
Other 16 (2.5%)
Required Intervention 2 (0.3%)
R 1 (0.2%)
Hospitalization 1 (0.2%)

Top Product Problems

No Device Output 270
Device Operates Differently Than Expected 97
Device Inoperable 60
Sticking 40
Loss of Power 30
Replace 22
Computer Operating System Problem 16
Device Issue 12
Difficult To Position 12
Device Stops Intermittently 11
Device Displays Incorrect Message 10
Failure to Power Up 10
No Display/Image 10
Repair 10
Self-Activation or Keying 8
Failure, intermittent 7
Smoking 7
Application Interface Becomes Non-Functional Or Program Exits Abnormally 6
Device Remains Activated 6
Failure to Align 6

Yearly Trend

94
1994: 1
95
1995: 1
96
1996: 3
97
1997: 2
98
1998: 1
01
2001: 1
02
2002: 3
06
2006: 2
07
2007: 2
08
2008: 138
09
2009: 178
10
2010: 106
11
2011: 172
12
2012: 21
13
2013: 2
14
2014: 1
16
2016: 1
20
2020: 2
22
2022: 1

Reports rose to 2 in 2020, up from an average of 1 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Table, Cystometric, Non-Electric And Accessories

Top Manufacturers

COVIDIEN 1

Event Locations

620 (97.2%)
HOSPITAL 14 (2.2%)
NO INFORMATION 3 (0.5%)
I 1 (0.2%)

Nationwide devices with a comparable report-volume footprint

Table carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (638 here).

Elevator, Surgical, Dental 638 Outpatient Cardiac Telemetry 638 Instrument, Ligature Passing And Knot Tying 635 Polymer Patient Examination Glove 635

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Table 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 Table; 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.