Bit, 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 MAUDE casebook
openFDA event book Bit, Surgical LIGHT-BOOK · MAUDE
#797 of 1000 · 622 reports · 2002–2026
- BOOK 622 reports
- RANK #797 of 1000
- DEATH 0 death-typed
- INJ 124 injury-typed
- MALF 494 malfunction
- SPAN 2002–2026
- PEAK 2025: 110
- PHOTO Accessories
Nearest event-volume peer: Accessories, Cleaning Brushes, For Endoscope (1 report gap)
Bit, Surgical sits #797 of 1000 among tracked device types with 622 MAUDE reports spanning 2002–2026. 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 19.9% corpus 30.4% · below corpus mean (-10.5 pp)
- MALF 79.4% corpus 64.5% · above corpus mean (+14.9 pp)
Lead product-problem code Break is 50% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 45% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .
Bit, Surgical in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Aberrometer
Aberrometer, Ophthalmic
626 reports
- Charger
Charger, Pacemaker
626 reports
- Bit, Surgical (this)
Bit, Surgical
622 reports
- Accessories
Accessories, Cleaning Brushes, For Endoscope
621 reports
- Integrated Co…
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
620 reports
- Monitor
Monitor, Apnea, Facility Use
620 reports
What this shows Bit, Surgical carries 622 MAUDE reports, ranked #797 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
Related Entities for Bit, Surgical
Top Manufacturers
Event Locations
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Bit, Surgical, 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 (622 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 Bit, 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 Bit, 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.