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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Instrument, Biopsy MID-BOOK · MAUDE

#128 of 1000 · 22,556 reports · 1994–2026

  • BOOK 22,556 reports
  • RANK #128 of 1000
  • DEATH 27 death-typed
  • INJ 1,866 injury-typed
  • MALF 20,401 malfunction
  • SPAN 1994–2026
  • PEAK 2020: 5,120
  • PHOTO Screwdriver

Nearest event-volume peer: Screwdriver (75 report gap)

Instrument, Biopsy sits #128 of 1000 among tracked device types with 22,556 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 →

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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 8.3% corpus 30.4% · below corpus mean (-22.2 pp)
  • MALF 90.4% corpus 64.5% · above corpus mean (+25.9 pp)

Lead product-problem code Failure to Fire is 32% of coded problems · Lead manufacturer BARD PERIPHERAL VASCULAR, INC. accounts for 86% of manufacturer-tagged reports · Top event location I is 55% of location-tagged rows .

Instrument, Biopsy in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Instrument, Biopsy carries 22,556 MAUDE reports, ranked #128 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 20,401 (90.4%)
Injury 1,866 (8.3%)
Other 185 (0.8%)
77 (0.3%)
Death 27 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

18,204 (80.1%)
Other 3,209 (14.1%)
Required Intervention 861 (3.8%)
Hospitalization 169 (0.7%)
R 132 (0.6%)
O 65 (0.3%)
Death 25 (0.1%)
Life Threatening 23 (0.1%)
Disability 22 (0.1%)
L 12 (0.1%)
H 10 (0.0%)
S 5 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Failure to Fire 6,062
Suction Problem 4,436
Failure to Obtain Sample 2,087
Self-Activation or Keying 1,816
Failure to Prime 739
Difficult to Remove 543
Adverse Event Without Identified Device or Use Problem 535
Break 401
Nonstandard Device 356
Device Contamination with Chemical or Other Material 324
Material Twisted/Bent 279
Leak/Splash 228
Detachment of Device or Device Component 197
Tear, Rip or Hole in Device Packaging 183
Device Operates Differently Than Expected 157
Device Markings/Labelling Problem 131
Material Fragmentation 96
Unintended Movement 96
Firing Problem 93
Misfire 82

Yearly Trend

94
1994: 2
95
1995: 16
96
1996: 26
97
1997: 55
98
1998: 107
99
1999: 146
00
2000: 199
01
2001: 222
02
2002: 148
03
2003: 107
04
2004: 251
05
2005: 389
06
2006: 743
07
2007: 766
08
2008: 363
09
2009: 351
10
2010: 162
11
2011: 67
12
2012: 93
13
2013: 98
14
2014: 193
15
2015: 591
16
2016: 297
17
2017: 760
18
2018: 1,012
19
2019: 4,195
20
2020: 5,120
21
2021: 1,020
22
2022: 535
23
2023: 931
24
2024: 1,283
25
2025: 1,695
26
2026: 613

Related Entities for Instrument, Biopsy

Top Manufacturers

BARD PERIPHERAL VASCULAR, INC. 15,568
ETHICON ENDO-SURGERY, INC. (CINCINNATI) 739
HOLOGIC, INC 666
ETHICON ENDO SURGERY, INC. (CINCINNATI) 500
HOLOGIC, INC. 263
ETHICON ENDO-SURGERY, INC. 176
ETHICON ENDO-SURGERY, LLC 170

Event Locations

I 12,326 (54.6%)
6,361 (28.2%)
NOT APPLICABLE 1,503 (6.7%)
HOSPITAL 1,195 (5.3%)
OTHER 776 (3.4%)
NO INFORMATION 203 (0.9%)
OUTPATIENT DIAGNOSTIC FACILITY 79 (0.4%)
AMBULATORY SURGICAL FACILITY 45 (0.2%)
OUTPATIENT TREATMENT FACILITY 42 (0.2%)
UNKNOWN 13 (0.1%)
INVALID DATA 10 (0.0%)
HOME 1 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)
RADIOLOGY DEPARTMENT 1 (0.0%)

Compare BARD PERIPHERAL VASCULAR, INC. vs ETHICON ENDO-SURGERY, INC. (CINCINNATI) →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Instrument, Biopsy, 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 (22,556 here).

Screwdriver 22,481 Mitral Valve Repair Devices 22,972 Prosthesis 22,129 Stent, Coronary 23,266

Similar death-typed counts

Nearest other device types by death-typed report count (27 here), distinct from the volume row.

Integrated Continuous Glucose Monitoring Sy… 27 Apparatus, Nitric Oxide Delivery 28 Biopsy Needle 26 Catheter 26

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.