Stapler, Surgical
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 §878.4740 (General Hospital panel).
FDA MAUDE casebook
openFDA event book Stapler, Surgical MID-BOOK · MAUDE
#113 of 1000 · 26,629 reports · 1992–2026
- BOOK 26,629 reports
- RANK #113 of 1000
- DEATH 276 death-typed
- INJ 6,719 injury-typed
- MALF 19,372 malfunction
- SPAN 1992–2026
- PEAK 1997: 3,606
- PHOTO System
Nearest event-volume peer: System, Thermal Regulating (18 report gap)
Stapler, Surgical sits #113 of 1000 among tracked device types with 26,629 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 → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Stapler, Surgical carries 72.7% MALFUNCTION-coded reports, 7.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.0% corpus 1.5% · near corpus mean (-0.5 pp)
- INJ 25.2% corpus 30.3% · below corpus mean (-5.1 pp)
- MALF 72.7% corpus 64.8% · above corpus mean (+7.9 pp)
Lead product-problem code Replace is 26% of coded problems · Lead manufacturer ETHICON ENDO-SURGERY, INC. accounts for 25% of manufacturer-tagged reports · Top event location NOT APPLICABLE is 38% of location-tagged rows .
Stapler, Surgical in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Coronavirus A…
Coronavirus Antigen Detection Test System.
26,743 reports
- Stapler (this)
Stapler, Surgical
26,629 reports
- System
System, Thermal Regulating
26,611 reports
- Test
Test, Time, Prothrombin
26,539 reports
- Wheelchair
Wheelchair, Mechanical
26,370 reports
- Device
Device, Neurovascular Embolization
26,211 reports
What this shows Stapler, Surgical carries 26,629 MAUDE reports, ranked #113 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 rose to 1,082 in 2025, up from an average of 618 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Stapler, Surgical
Top Manufacturers
Event Locations
Compare ETHICON ENDO-SURGERY, INC. vs UNITED STATES SURGICAL CORP. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Stapler, Surgical: 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 (26,629 here).
Similar death-typed counts
Nearest other device types by death-typed report count (276 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Stapler, Surgical 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 Stapler, Surgical; 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.