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2026 data FDA MAUDE openFDA FDA Class II

Rongeur, Manual

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 §882.4840 (Neurology panel).

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FDA MAUDE casebook

openFDA event book Rongeur, Manual LIGHT-BOOK · MAUDE

#906 of 1000 · 482 reports · 1993–2026

  • BOOK 482 reports
  • RANK #906 of 1000
  • DEATH 1 death-typed
  • INJ 82 injury-typed
  • MALF 334 malfunction
  • SPAN 1993–2026
  • PEAK 2012: 47
  • PHOTO Cardiac Catheterizati…

Nearest event-volume peer: Cardiac Catheterization Kit (1 report gap)

Rongeur, Manual sits #906 of 1000 among tracked device types with 482 MAUDE reports spanning 1993–2026. 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 →

Injury-coded reports sit below the device-type norm

Rongeur, Manual carries 17.0% INJURY-coded reports, 13.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 17.0% corpus 30.3% · below corpus mean (-13.3 pp)
  • MALF 69.3% corpus 64.8% · above corpus mean (+4.5 pp)

Lead product-problem code Break is 37% of coded problems · Lead manufacturer CAREFUSION, INC accounts for 64% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Rongeur, Manual in the event-volume neighbourhood

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

reports

What this shows Rongeur, Manual carries 482 MAUDE reports, ranked #906 of 1000.

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

Event Types

Malfunction 334 (69.3%)
Injury 82 (17.0%)
Other 58 (12.0%)
7 (1.5%)
Death 1 (0.2%)

Patient Outcomes

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

254 (52.0%)
Other 130 (26.6%)
Required Intervention 90 (18.4%)
R 6 (1.2%)
Hospitalization 5 (1.0%)
Death 2 (0.4%)
Life Threatening 1 (0.2%)

Top Product Problems

Break 186
Detachment Of Device Component 42
Insufficient Device Problem Information 30
Fracture 27
Tip breakage 26
Device Operates Differently Than Expected 25
Component Falling 23
Detachment of Device or Device Component 20
Device, or device fragments remain in patient 16
Material Separation 14
Component Missing 12
Difficult to Remove 11
Other (for use when an appropriate device code cannot be identified) 10
Sticking 10
Material Fragmentation 9
Appropriate Device Problem Term/Code Not Available 8
Device Fell 8
Dent in Material 7
Device Or Device Fragments Location Unknown 7
Inadequate Service 7

Yearly Trend

93
1993: 2
94
1994: 1
95
1995: 1
96
1996: 2
97
1997: 13
98
1998: 4
99
1999: 9
00
2000: 13
01
2001: 7
02
2002: 19
03
2003: 23
04
2004: 17
05
2005: 5
06
2006: 3
07
2007: 4
08
2008: 5
09
2009: 6
10
2010: 10
11
2011: 31
12
2012: 47
13
2013: 20
14
2014: 15
15
2015: 25
16
2016: 34
17
2017: 25
18
2018: 29
19
2019: 24
20
2020: 25
21
2021: 12
22
2022: 13
23
2023: 10
24
2024: 9
25
2025: 10
26
2026: 9

Reports in 2025 (10) held close to the prior two-year average of 10.

Related Entities for Rongeur, Manual

Top Manufacturers

CAREFUSION, INC 23
CAREFUSION 13

Event Locations

248 (51.5%)
I 124 (25.7%)
HOSPITAL 90 (18.7%)
NO INFORMATION 12 (2.5%)
INVALID DATA 6 (1.2%)
OTHER 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare CAREFUSION, INC vs CAREFUSION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Rongeur, Manual: 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 (482 here).

Cardiac Catheterization Kit 481 Cane 484 Patient Examination Glove 484 Enzyme Immunoassay, Digoxin 478

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Rongeur, Manual 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 Rongeur, Manual; 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.