What are FDA adverse event reports for General Surgery Tray?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For General Surgery Tray, there are 17,567 total reports including 2 death reports and 1,414 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for General Surgery Tray?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

General Surgery Tray

Name: General Surgery Tray - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book General Surgery Tray MID-BOOK · MAUDE

#147 of 1000 · 17,567 reports · 1996–2026

BOOK 17,567 reports
RANK #147 of 1000
DEATH 2 death-typed
INJ 1,414 injury-typed
MALF 16,006 malfunction
SPAN 1996–2026
PEAK 2025: 5,556
PHOTO Implant

Nearest event-volume peer: Implant, Intragastric For Morbid Obesity (21 report gap)

General Surgery Tray sits #147 of 1000 among tracked device types with 17,567 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 →

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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
INJ 8.0% corpus 30.4% · below corpus mean (-22.4 pp)
MALF 91.1% corpus 64.5% · above corpus mean (+26.6 pp)

Lead product-problem code Failure to Cut is 38% of coded problems · Lead manufacturer ALCON RESEARCH, LLC - HOUSTON accounts for 99% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .

Immunoassay M…

17,726
Implant

17,588
General Surge… (this)

17,567
Device

17,504
Leadless Pace…

17,499
Phakic Toric…

17,499

What this shows General Surgery Tray carries 17,567 MAUDE reports, ranked #147 of 1000.

Event Types

Malfunction 16,006 (91.1%)

Injury 1,414 (8.0%)

Other 119 (0.7%)

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.

13,795 (77.0%)

Other 3,069 (17.1%)

Required Intervention 558 (3.1%)

R 251 (1.4%)

O 158 (0.9%)

Hospitalization 45 (0.3%)

H 25 (0.1%)

S 7 (0.0%)

Disability 7 (0.0%)

Life Threatening 7 (0.0%)

Congenital Anomaly 2 (0.0%)

Death 2 (0.0%)

Yearly Trend

1996: 2

1997: 12

1998: 17

1999: 20

2000: 19

2001: 32

2002: 27

2003: 22

2004: 24

2005: 22

2006: 15

2007: 8

2008: 8

2009: 5

2010: 23

2011: 17

2012: 64

2013: 25

2014: 59

2015: 628

2016: 805

2017: 523

2018: 384

2019: 406

2020: 767

2021: 920

2022: 1,134

2023: 1,913

2024: 3,031

2025: 5,556

2026: 1,079

Top Manufacturers

ALCON RESEARCH, LLC - HOUSTON 13,478

CARDINAL HEALTH 103

Event Locations

13,238 (75.4%)

I 3,519 (20.0%)

HOSPITAL 625 (3.6%)

NO INFORMATION 137 (0.8%)

AMBULATORY SURGICAL FACILITY 26 (0.1%)

OTHER 8 (0.0%)

INVALID DATA 5 (0.0%)

OUTPATIENT TREATMENT FACILITY 3 (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 CARDINAL HEALTH →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for General Surgery Tray, 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 (17,567 here).

Implant, Intragastric For Morbid Obesity 17,588 Device, Incontinence, Mechanical/Hydraulic 17,504 Leadless Pacemaker 17,499 Phakic Toric Intraocular Lens 17,499

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 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.

General Surgery Tray

Event-type mix vs corpus