Stool, Operating-Room
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 §878.4950 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Stool, Operating-Room LIGHT-BOOK · MAUDE
#979 of 1000 · 392 reports · 1997–2026
- BOOK 392 reports
- RANK #979 of 1000
- DEATH 0 death-typed
- INJ 2 injury-typed
- MALF 388 malfunction
- SPAN 1997–2026
- PEAK 2015: 59
- PHOTO Accessories
Nearest event-volume peer: Accessories, Catheter, G-U (0 report gap)
Stool, Operating-Room sits #979 of 1000 among tracked device types with 392 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 →
Malfunction reports run above the device-type norm
Stool, Operating-Room carries 99.0% MALFUNCTION-coded reports, 34.2pp 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 0.5% corpus 30.3% · below corpus mean (-29.8 pp)
- MALF 99.0% corpus 64.8% · above corpus mean (+34.2 pp)
Lead product-problem code Device Slipped is 33% of coded problems · Lead manufacturer STRYKER MEDICAL-KALAMAZOO accounts for 83% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .
Stool, Operating-Room in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Alkaline Picr…
Alkaline Picrate, Colorimetry, Creatinine
394 reports
- Needle
Needle, Catheter
394 reports
- Perforator
Perforator, Ear-Lobe
393 reports
- Stool (this)
Stool, Operating-Room
392 reports
- Accessories
Accessories, Catheter, G-U
392 reports
- Controller
Controller, Foot, Handpiece And Cord
392 reports
What this shows Stool, Operating-Room carries 392 MAUDE reports, ranked #979 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (12) held close to the prior two-year average of 11.
Related Entities for Stool, Operating-Room
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Stool, Operating-Room 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 (392 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
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.