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2026 data FDA MAUDE openFDA FDA Class II

Biopsy Needle

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).

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FDA MAUDE casebook

openFDA event book Biopsy Needle LIGHT-BOOK · MAUDE

#323 of 1000 · 4,892 reports · 1992–2026

  • BOOK 4,892 reports
  • RANK #323 of 1000
  • DEATH 27 death-typed
  • INJ 1,014 injury-typed
  • MALF 3,830 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 642
  • PHOTO Lavage, Jet

Nearest event-volume peer: Lavage, Jet (4 report gap)

Biopsy Needle sits #323 of 1000 among tracked device types with 4,892 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

Biopsy Needle carries 78.3% MALFUNCTION-coded reports, 13.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 20.7% corpus 30.3% · below corpus mean (-9.6 pp)
  • MALF 78.3% corpus 64.8% · above corpus mean (+13.5 pp)

Lead product-problem code Break is 28% of coded problems · Lead manufacturer COOK IRELAND LTD accounts for 44% of manufacturer-tagged reports · Top event location is 46% of location-tagged rows .

Biopsy Needle in the event-volume neighbourhood

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

reports

What this shows Biopsy Needle carries 4,892 MAUDE reports, ranked #323 of 1000.

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

Event Types

Malfunction 3,830 (78.3%)
Injury 1,014 (20.7%)
Death 27 (0.6%)
13 (0.3%)
Other 8 (0.2%)

Patient Outcomes

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

3,715 (73.8%)
Required Intervention 683 (13.6%)
Other 316 (6.3%)
R 109 (2.2%)
Hospitalization 102 (2.0%)
O 32 (0.6%)
Death 23 (0.5%)
H 20 (0.4%)
Life Threatening 11 (0.2%)
L 10 (0.2%)
D 7 (0.1%)
S 3 (0.1%)
Disability 1 (0.0%)

Top Product Problems

Break 1,295
Fracture 414
Material Twisted/Bent 384
Retraction Problem 328
Adverse Event Without Identified Device or Use Problem 291
Improper or Incorrect Procedure or Method 228
Detachment of Device or Device Component 193
Misfire 172
Bent 166
Off-Label Use 165
Occlusion Within Device 158
Difficult to Remove 148
Device Contamination with Chemical or Other Material 121
Physical Resistance/Sticking 117
Detachment Of Device Component 104
Material Separation 93
Loose 91
Kinked 81
Material Perforation 78
Failure to Advance 68

Yearly Trend

92
1992: 1
93
1993: 1
99
1999: 6
00
2000: 8
01
2001: 6
02
2002: 6
03
2003: 13
04
2004: 7
05
2005: 10
06
2006: 18
07
2007: 11
08
2008: 115
09
2009: 270
10
2010: 73
11
2011: 71
12
2012: 107
13
2013: 130
14
2014: 154
15
2015: 124
16
2016: 191
17
2017: 273
18
2018: 282
19
2019: 229
20
2020: 240
21
2021: 290
22
2022: 302
23
2023: 428
24
2024: 446
25
2025: 642
26
2026: 438

Reports rose to 642 in 2025, up from an average of 437 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Biopsy Needle

Top Manufacturers

COOK IRELAND LTD 1,773
BARD PERIPHERAL VASCULAR, INC. 747
AOMORI OLYMPUS CO., LTD. 542
BOSTON SCIENTIFIC - SPENCER 273
OLYMPUS MEDICAL SYSTEMS CORP. 259
BOSTON SCIENTIFIC CORPORATION 172
GYRUS ACMI, INC. 123
CAREFUSION 84
COOK ENDOSCOPY 71

Event Locations

2,239 (45.8%)
HOSPITAL 2,017 (41.2%)
I 561 (11.5%)
NO INFORMATION 49 (1.0%)
OUTPATIENT DIAGNOSTIC FACILITY 7 (0.1%)
OUTPATIENT TREATMENT FACILITY 7 (0.1%)
OTHER 6 (0.1%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
HOME 3 (0.1%)

Compare COOK IRELAND LTD vs BARD PERIPHERAL VASCULAR, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Biopsy Needle: 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 (4,892 here).

Lavage, Jet 4,888 Accessories, Implant, Dental, Endosseous 4,902 Lenses, Soft Contact, Daily Wear 4,868 Catheter, Flow Directed 4,863

Similar death-typed counts

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

Agent 27 Extracorporeal System For Long-Term Respira… 27 Instrument, Biopsy 27 Stimulator 27

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Biopsy Needle 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 Biopsy Needle; 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.