Cutter, 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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4800 (General, Plastic Surgery panel).
FDA MAUDE casebook
openFDA event book Cutter, Surgical LIGHT-BOOK · MAUDE
#822 of 1000 · 607 reports · 1992–2026
- BOOK 607 reports
- RANK #822 of 1000
- DEATH 0 death-typed
- INJ 24 injury-typed
- MALF 580 malfunction
- SPAN 1992–2026
- PEAK 2024: 84
- PHOTO Unit
Nearest event-volume peer: Unit, Liquid-Oxygen, Portable (0 report gap)
Cutter, Surgical sits #822 of 1000 among tracked device types with 607 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
Cutter, Surgical carries 95.6% MALFUNCTION-coded reports, 30.7pp 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 4.0% corpus 30.3% · below corpus mean (-26.3 pp)
- MALF 95.6% corpus 64.8% · above corpus mean (+30.7 pp)
Lead product-problem code Degraded is 32% of coded problems · Lead manufacturer DEPUY MITEK LLC US accounts for 85% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .
Cutter, Surgical in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Endoscope
Endoscope, Accessories, Image Post-Processing For Color Enhancement
608 reports
- Cutter (this)
Cutter, Surgical
607 reports
- Unit
Unit, Liquid-Oxygen, Portable
607 reports
- Source
Source, Brachytherapy, Radionuclide
606 reports
- Probe
Probe
602 reports
- Table
Table, Obstetric (And Accessories)
602 reports
What this shows Cutter, Surgical carries 607 MAUDE reports, ranked #822 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 (57) held close to the prior two-year average of 71.
Related Entities for Cutter, Surgical
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Cutter, Surgical 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 (607 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 Cutter, 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 Cutter, 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.