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2026 data FDA MAUDE openFDA FDA Class I

Processor, Tissue, 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 Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §864.3875 (Pathology panel).

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FDA MAUDE casebook

openFDA event book Processor, Tissue, Automated LIGHT-BOOK · MAUDE

#543 of 1000 · 1,657 reports · 1992–2026

  • BOOK 1,657 reports
  • RANK #543 of 1000
  • DEATH 0 death-typed
  • INJ 826 injury-typed
  • MALF 800 malfunction
  • SPAN 1992–2026
  • PEAK 2022: 169
  • PHOTO Set

Nearest event-volume peer: Set, Tubing And Support, Ventilator (W Harness) (3 report gap)

Processor, Tissue, Automated sits #543 of 1000 among tracked device types with 1,657 MAUDE reports spanning 1992–2026. 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 → · Similar-volume device →

Injury-coded reports run above the device-type norm

Processor, Tissue, Automated carries 49.8% INJURY-coded reports, 19.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 49.8% corpus 30.3% · above corpus mean (+19.6 pp)
  • MALF 48.3% corpus 64.8% · below corpus mean (-16.5 pp)

Lead product-problem code Improper or Incorrect Procedure or Method is 40% of coded problems · Top event location is 48% of location-tagged rows .

Processor, Tissue, Automated in the event-volume neighbourhood

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

reports

What this shows Processor, Tissue, Automated carries 1,657 MAUDE reports, ranked #543 of 1000.

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

Event Types

Injury 826 (49.8%)
Malfunction 800 (48.3%)
23 (1.4%)
Other 8 (0.5%)

Patient Outcomes

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

810 (47.5%)
Other 546 (32.0%)
Required Intervention 289 (17.0%)
R 46 (2.7%)
Hospitalization 3 (0.2%)
O 2 (0.1%)
S 2 (0.1%)
Death 2 (0.1%)
Invalid Data 2 (0.1%)
Congenital Anomaly 1 (0.1%)
Disability 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Improper or Incorrect Procedure or Method 705
Adverse Event Without Identified Device or Use Problem 397
Device Operates Differently Than Expected 192
Use of Device Problem 90
Insufficient Device Problem Information 78
Product Quality Problem 74
Device Displays Incorrect Message 42
Appropriate Device Problem Term/Code Not Available 32
Failure to Obtain Sample 24
Leak/Splash 21
Therapeutic or Diagnostic Output Failure 18
Defective Component 16
Device Ingredient or Reagent Problem 14
Device Emits Odor 9
Mechanical Problem 9
Nonstandard Device 9
Failure to Cut 8
Incorrect Or Inadequate Test Results 8
Output below Specifications 8
Failure to Cycle 7

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 1
95
1995: 2
96
1996: 1
97
1997: 2
00
2000: 2
01
2001: 2
03
2003: 4
04
2004: 4
05
2005: 13
06
2006: 2
08
2008: 13
09
2009: 12
10
2010: 69
11
2011: 91
12
2012: 76
13
2013: 90
14
2014: 84
15
2015: 106
16
2016: 124
17
2017: 124
18
2018: 158
19
2019: 78
20
2020: 78
21
2021: 126
22
2022: 169
23
2023: 67
24
2024: 63
25
2025: 68
26
2026: 26

Reports in 2025 (68) held close to the prior two-year average of 65.

Related Entities for Processor, Tissue, Automated

Event Locations

789 (47.6%)
I 598 (36.1%)
HOSPITAL 152 (9.2%)
OTHER 99 (6.0%)
NO INFORMATION 15 (0.9%)
INVALID DATA 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Nationwide devices with a comparable report-volume footprint

Processor, Tissue, Automated 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 (1,657 here).

Set, Tubing And Support, Ventilator 1,654 Adhesive 1,663 Laryngoscope, Endoscope 1,664 Microfilter, Blood Transfusion 1,648

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 Processor, Tissue, Automated 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, Tissue, Automated; 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.