Instrument, Biopsy
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 §876.1075 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Instrument, Biopsy MID-BOOK · MAUDE
#128 of 1000 · 23,840 reports · 1994–2026
- BOOK 23,840 reports
- RANK #128 of 1000
- DEATH 27 death-typed
- INJ 1,974 injury-typed
- MALF 21,577 malfunction
- SPAN 1994–2026
- PEAK 2020: 5,120
- PHOTO Duodenoscope And Acce…
Nearest event-volume peer: Duodenoscope And Accessories, Flexible/Rigid (261 report gap)
Instrument, Biopsy sits #128 of 1000 among tracked device types with 23,840 MAUDE reports spanning 1994–2026. 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
Instrument, Biopsy carries 90.5% MALFUNCTION-coded reports, 25.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 8.3% corpus 30.3% · below corpus mean (-22.0 pp)
- MALF 90.5% corpus 64.8% · above corpus mean (+25.7 pp)
Lead product-problem code Failure to Fire is 30% of coded problems · Lead manufacturer BARD PERIPHERAL VASCULAR, INC. accounts for 86% of manufacturer-tagged reports · Top event location I is 52% of location-tagged rows .
Instrument, Biopsy in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Programmer
Programmer, Pacemaker
24,159 reports
- Duodenoscope…
Duodenoscope And Accessories, Flexible/Rigid
24,101 reports
- Instrument (this)
Instrument, Biopsy
23,840 reports
- Counter
Counter, Differential Cell
23,439 reports
- Stent
Stent, Coronary
23,279 reports
- Screwdriver
Screwdriver
23,256 reports
What this shows Instrument, Biopsy carries 23,840 MAUDE reports, ranked #128 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 1,695 in 2025, up from an average of 1,107 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Instrument, Biopsy
Top Manufacturers
Event Locations
Compare BARD PERIPHERAL VASCULAR, INC. vs ETHICON ENDO-SURGERY, INC. (CINCINNATI) →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Instrument, Biopsy: 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 (23,840 here).
Similar death-typed counts
Nearest other device types by death-typed report count (27 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Instrument, Biopsy 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 Instrument, Biopsy; 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.