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2026 data FDA MAUDE openFDA FDA Class I

Forceps, Biopsy, Non-Electric

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 §876.1075 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Forceps, Biopsy, Non-Electric LIGHT-BOOK · MAUDE

#434 of 1000 · 2,705 reports · 1992–2026

  • BOOK 2,705 reports
  • RANK #434 of 1000
  • DEATH 17 death-typed
  • INJ 704 injury-typed
  • MALF 1,954 malfunction
  • SPAN 1992–2026
  • PEAK 2010: 498
  • PHOTO Bur

Nearest event-volume peer: Bur, Ear, Nose And Throat (9 report gap)

Forceps, Biopsy, Non-Electric sits #434 of 1000 among tracked device types with 2,705 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

Forceps, Biopsy, Non-Electric carries 72.2% MALFUNCTION-coded reports, 7.4pp 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 (-0.9 pp)
  • INJ 26.0% corpus 30.3% · below corpus mean (-4.3 pp)
  • MALF 72.2% corpus 64.8% · above corpus mean (+7.4 pp)

Lead product-problem code Device Operates Differently Than Expected is 17% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 43% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Forceps, Biopsy, Non-Electric in the event-volume neighbourhood

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

reports

What this shows Forceps, Biopsy, Non-Electric carries 2,705 MAUDE reports, ranked #434 of 1000.

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

Event Types

Malfunction 1,954 (72.2%)
Injury 704 (26.0%)
Other 18 (0.7%)
Death 17 (0.6%)
12 (0.4%)

Patient Outcomes

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

1,950 (69.4%)
Required Intervention 370 (13.2%)
Other 228 (8.1%)
Hospitalization 134 (4.8%)
R 84 (3.0%)
O 15 (0.5%)
Death 14 (0.5%)
H 4 (0.1%)
L 3 (0.1%)
D 2 (0.1%)
Disability 2 (0.1%)
S 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Device Operates Differently Than Expected 429
Adverse Event Without Identified Device or Use Problem 323
Bent 276
Break 244
Appropriate Device Problem Term/Code Not Available 199
Other (for use when an appropriate device code cannot be identified) 172
Difficult to Open or Close 137
Detachment Of Device Component 109
Failure to Cut 82
Insufficient Device Problem Information 77
Difficult to Remove 72
Close, difficult to 63
Dull, Blunt 55
Device Contamination with Chemical or Other Material 53
Wire(s), breakage of 50
Fracture 46
Unknown (for use when the device problem is not known) 46
Material Separation 40
Failure to Align 35
Mechanical Problem 35

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 3
95
1995: 1
96
1996: 4
97
1997: 2
98
1998: 2
00
2000: 7
01
2001: 11
02
2002: 4
03
2003: 8
04
2004: 6
05
2005: 5
06
2006: 27
07
2007: 58
08
2008: 153
09
2009: 410
10
2010: 498
11
2011: 377
12
2012: 97
13
2013: 58
14
2014: 86
15
2015: 51
16
2016: 64
17
2017: 275
18
2018: 69
19
2019: 69
20
2020: 53
21
2021: 30
22
2022: 70
23
2023: 68
24
2024: 60
25
2025: 56
26
2026: 21

Reports in 2025 (56) held close to the prior two-year average of 64.

Related Entities for Forceps, Biopsy, Non-Electric

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 716
COOK ENDOSCOPY 467
BOSTON SCIENTIFIC - COSTA RICA (COYOL) 178
OLYMPUS MEDICAL SYSTEMS CORP. 132
WILSON-COOK MEDICAL INC 51
AOMORI OLYMPUS CO., LTD. 45
WILSON-COOK MEDICAL INC. 42
COOK IRELAND LTD 38

Event Locations

1,934 (71.5%)
HOSPITAL 440 (16.3%)
I 263 (9.7%)
NO INFORMATION 29 (1.1%)
AMBULATORY SURGICAL FACILITY 14 (0.5%)
OUTPATIENT TREATMENT FACILITY 11 (0.4%)
OTHER 5 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.1%)
HOME 2 (0.1%)
INVALID DATA 1 (0.0%)
OPERATING ROOM 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs COOK ENDOSCOPY →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Forceps, Biopsy, Non-Electric: 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 (2,705 here).

Bur, Ear, Nose And Throat 2,714 Vehicle, Motorized 3-Wheeled 2,715 Drills, Burrs, Trephines & Accessories 2,726 Prosthesis, Hip, Hemi-, Femoral, Metal 2,683

Similar death-typed counts

Nearest other device types by death-typed report count (17 here), distinct from the volume row.

Accessories, Blood Circuit, Hemodialysis 17 Cable, Transducer And Electrode, Patient, 17 Cardiovascular Procedure Kit 17 Counter, Differential Cell 17

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

Disclaimer: MAUDE figures for Forceps, Biopsy, Non-Electric 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 Forceps, Biopsy, Non-Electric; 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.