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2026 data FDA MAUDE openFDA FDA Class II

General Surgery Tray

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 §878.4370 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book General Surgery Tray MID-BOOK · MAUDE

#137 of 1000 · 20,596 reports · 1996–2026

  • BOOK 20,596 reports
  • RANK #137 of 1000
  • DEATH 2 death-typed
  • INJ 1,528 injury-typed
  • MALF 18,921 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 5,555
  • PHOTO Orthopedic Stereotaxi…

Nearest event-volume peer: Orthopedic Stereotaxic Instrument (268 report gap)

General Surgery Tray sits #137 of 1000 among tracked device types with 20,596 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 →

Malfunction reports run above the device-type norm

General Surgery Tray carries 91.9% MALFUNCTION-coded reports, 27.0pp 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 7.4% corpus 30.3% · below corpus mean (-22.9 pp)
  • MALF 91.9% corpus 64.8% · above corpus mean (+27.0 pp)

Lead product-problem code Failure to Cut is 38% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - HOUSTON accounts for 98% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .

General Surgery Tray in the event-volume neighbourhood

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

reports

What this shows General Surgery Tray carries 20,596 MAUDE reports, ranked #137 of 1000.

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

Event Types

Malfunction 18,921 (91.9%)
Injury 1,528 (7.4%)
Other 119 (0.6%)
25 (0.1%)
Death 2 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

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

14,996 (77.9%)
Other 3,159 (16.4%)
Required Intervention 565 (2.9%)
R 257 (1.3%)
O 163 (0.8%)
Hospitalization 45 (0.2%)
H 26 (0.1%)
Disability 9 (0.0%)
S 7 (0.0%)
Life Threatening 7 (0.0%)
Congenital Anomaly 2 (0.0%)
Death 2 (0.0%)

Top Product Problems

Failure to Cut 7,479
Suction Problem 2,530
Leak/Splash 1,742
Suction Failure 1,490
Break 948
Fluid/Blood Leak 815
Adverse Event Without Identified Device or Use Problem 529
Obstruction of Flow 526
Material Twisted/Bent 485
Infusion or Flow Problem 360
Ambient Noise Problem 348
Inability to Irrigate 332
Air/Gas in Device 306
Complete Blockage 300
Dull, Blunt 277
Contamination /Decontamination Problem 243
Device Contamination with Chemical or Other Material 220
Incomplete or Inadequate Connection 200
Detachment of Device or Device Component 196
Contamination 195

Yearly Trend

96
1996: 2
97
1997: 12
98
1998: 17
99
1999: 20
00
2000: 19
01
2001: 32
02
2002: 27
03
2003: 22
04
2004: 24
05
2005: 22
06
2006: 15
07
2007: 8
08
2008: 8
09
2009: 5
10
2010: 25
11
2011: 17
12
2012: 64
13
2013: 25
14
2014: 59
15
2015: 628
16
2016: 805
17
2017: 523
18
2018: 384
19
2019: 406
20
2020: 767
21
2021: 920
22
2022: 1,134
23
2023: 1,913
24
2024: 3,031
25
2025: 5,555
26
2026: 4,107

Reports rose to 5,555 in 2025, up from an average of 2,472 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for General Surgery Tray

Top Manufacturers

ALCON RESEARCH, LLC - HOUSTON 16,074
MEDLINE INDUSTRIES, LP 157
Alcon Research, LLC - Houston 110
CARDINAL HEALTH 104

Event Locations

16,242 (78.9%)
I 3,519 (17.1%)
HOSPITAL 648 (3.1%)
NO INFORMATION 137 (0.7%)
AMBULATORY SURGICAL FACILITY 26 (0.1%)
OTHER 9 (0.0%)
INVALID DATA 5 (0.0%)
OUTPATIENT TREATMENT FACILITY 4 (0.0%)
UNKNOWN 3 (0.0%)
HOME 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare ALCON RESEARCH, LLC - HOUSTON vs MEDLINE INDUSTRIES, LP →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for General Surgery Tray: 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 (20,596 here).

Orthopedic Stereotaxic Instrument 20,328 Reagents 20,142 Catheter, Intravascular, Diagnostic 20,128 Suture 20,010

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 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for General Surgery Tray 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 General Surgery Tray; 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.