What are FDA adverse event reports for Stool, Operating-Room?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Stool, Operating-Room, there are 386 total reports including 0 death reports and 2 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 Stool, Operating-Room?

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

Stool, Operating-Room

Name: Stool, Operating-Room - 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 Stool, Operating-Room LIGHT-BOOK · MAUDE

#964 of 1000 · 386 reports · 1997–2026

BOOK 386 reports
RANK #964 of 1000
DEATH 0 death-typed
INJ 2 injury-typed
MALF 382 malfunction
SPAN 1997–2026
PEAK 2015: 59
PHOTO Catheter

Nearest event-volume peer: Catheter, Cholangiography (2 report gap)

Stool, Operating-Room sits #964 of 1000 among tracked device types with 386 MAUDE reports spanning 1997–2026. 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 0.5% corpus 30.4% · below corpus mean (-29.9 pp)
MALF 99.0% corpus 64.5% · above corpus mean (+34.5 pp)

Lead product-problem code Device Slipped is 27% of coded problems · Lead manufacturer STRYKER MEDICAL-KALAMAZOO accounts for 83% of manufacturer-tagged reports · Top event location is 78% of location-tagged rows .

Accessories

390
Controller

388
Lead

388
Stool (this)

386
Catheter

384
Refrigerator

383

What this shows Stool, Operating-Room carries 386 MAUDE reports, ranked #964 of 1000.

Event Types

Malfunction 382 (99.0%)

Injury 2 (0.5%)

1 (0.3%)

Other 1 (0.3%)

Patient Outcomes

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

384 (99.5%)

Other 2 (0.5%)

Yearly Trend

1997: 6

2009: 1

2010: 42

2011: 54

2012: 14

2013: 46

2014: 58

2015: 59

2017: 14

2018: 17

2019: 4

2020: 13

2021: 13

2022: 10

2023: 12

2024: 9

2025: 12

2026: 2

Top Manufacturers

STRYKER MEDICAL-KALAMAZOO 268

STRYKER MEDICAL 53

Event Locations

303 (78.5%)

I 80 (20.7%)

NO INFORMATION 2 (0.5%)

INVALID DATA 1 (0.3%)

Compare STRYKER MEDICAL-KALAMAZOO vs STRYKER MEDICAL →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stool, Operating-Room, 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 (386 here).

Catheter, Cholangiography 384 Controller, Foot, Handpiece And Cord 388 Lead, Atomic Absorption 388 Refrigerator, Freezer, Blood Storage 383

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 Stool, Operating-Room 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 Stool, Operating-Room; 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.

Stool, Operating-Room

Event-type mix vs corpus