2026 data FDA MAUDE openFDA FDA Class III

Processor, Cervical Cytology Slide, Automated

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 MAUDE casebook

openFDA event book Processor LIGHT-BOOK · MAUDE

#961 of 1000 · 410 reports · 1996–2026

  • BOOK 410 reports
  • RANK #961 of 1000
  • DEATH 0 death-typed
  • INJ 40 injury-typed
  • MALF 242 malfunction
  • SPAN 1996–2026
  • PEAK 2023: 77
  • PHOTO Enzyme Immunoassay

Nearest event-volume peer: Enzyme Immunoassay, Phenobarbital (1 report gap)

Processor, Cervical Cytology Slide, Automated sits #961 of 1000 among tracked device types with 410 MAUDE reports spanning 1996–2026. 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 →

Injury-coded reports sit below the device-type norm

Processor carries 9.8% INJURY-coded reports, 20.5pp below 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 9.8% corpus 30.3% · below corpus mean (-20.5 pp)
  • MALF 59.0% corpus 64.8% · below corpus mean (-5.8 pp)

Lead product-problem code Leak/Splash is 19% of coded problems · Lead manufacturer BECTON, DICKINSON & CO. (SPARKS) accounts for 29% of manufacturer-tagged reports · Top event location is 83% of location-tagged rows .

Processor in the event-volume neighbourhood

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

reports

What this shows Processor, Cervical Cytology Slide, Automated carries 410 MAUDE reports, ranked #961 of 1000.

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

Event Types

Malfunction 242 (59.0%)
Other 74 (18.0%)
54 (13.2%)
Injury 40 (9.8%)

Patient Outcomes

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

244 (57.8%)
Other 146 (34.6%)
R 12 (2.8%)
Required Intervention 11 (2.6%)
Hospitalization 8 (1.9%)
Life Threatening 1 (0.2%)

Top Product Problems

Leak/Splash 74
Contamination 48
Device Markings/Labelling Problem 35
Device Operates Differently Than Expected 29
Device Displays Incorrect Message 21
Improper or Incorrect Procedure or Method 21
Structural Problem 21
Break 18
Spillage, accidental 18
False Negative Result 17
Incorrect, Inadequate or Imprecise Result or Readings 16
Use of Device Problem 16
Fluid/Blood Leak 11
Computer Operating System Problem 10
Image Display Error/Artifact 8
Unknown (for use when the device problem is not known) 8
Insufficient Device Problem Information 7
Crack 5
Display Difficult to Read 5
Device Emits Odor 4

Yearly Trend

96
1996: 1
97
1997: 1
98
1998: 1
99
1999: 5
00
2000: 4
01
2001: 3
03
2003: 6
04
2004: 6
05
2005: 9
06
2006: 4
07
2007: 7
08
2008: 8
09
2009: 6
10
2010: 18
11
2011: 19
12
2012: 6
13
2013: 6
14
2014: 16
15
2015: 22
16
2016: 28
17
2017: 6
18
2018: 2
20
2020: 1
21
2021: 24
22
2022: 17
23
2023: 77
24
2024: 56
25
2025: 38
26
2026: 13

Reports fell to 38 in 2025, down from an average of 67 in the two years before.

Related Entities for Processor, Cervical Cytology Slide, Automated

Event Locations

340 (82.9%)
I 62 (15.1%)
HOSPITAL 3 (0.7%)
NO INFORMATION 2 (0.5%)
OTHER 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare BECTON, DICKINSON & CO. (SPARKS) vs BECTON DICKINSON & CO. (SPARKS) →

Nationwide devices with a comparable report-volume footprint

Processor 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 (410 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Processor 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 Processor; 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.