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2026 data FDA MAUDE openFDA FDA Class I

Blade, Scalpel

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 §878.4800 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Blade, Scalpel LIGHT-BOOK · MAUDE

#674 of 1000 · 970 reports · 1992–2026

  • BOOK 970 reports
  • RANK #674 of 1000
  • DEATH 0 death-typed
  • INJ 238 injury-typed
  • MALF 675 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 125
  • PHOTO Pump

Nearest event-volume peer: Pump, Portable, Aspiration (Manual Or Powered) (2 report gap)

Blade, Scalpel sits #674 of 1000 among tracked device types with 970 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 →

Injury-coded reports sit below the device-type norm

Blade, Scalpel carries 24.5% INJURY-coded reports, 5.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 24.5% corpus 30.3% · below corpus mean (-5.8 pp)
  • MALF 69.6% corpus 64.8% · above corpus mean (+4.8 pp)

Lead product-problem code Break is 53% of coded problems · Lead manufacturer AESCULAP AG accounts for 41% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Blade, Scalpel in the event-volume neighbourhood

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

reports

What this shows Blade, Scalpel carries 970 MAUDE reports, ranked #674 of 1000.

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

Event Types

Malfunction 675 (69.6%)
Injury 238 (24.5%)
Other 44 (4.5%)
13 (1.3%)

Patient Outcomes

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

582 (55.1%)
Other 234 (22.2%)
Required Intervention 139 (13.2%)
R 79 (7.5%)
Hospitalization 13 (1.2%)
O 3 (0.3%)
L 2 (0.2%)
S 2 (0.2%)
H 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 488
Detachment Of Device Component 50
Tear, Rip or Hole in Device Packaging 47
Dull, Blunt 44
Difficult to Remove 26
Unsealed Device Packaging 26
Fracture 25
Material Integrity Problem 23
Tip breakage 23
Insufficient Device Problem Information 22
Component Falling 21
Device Operates Differently Than Expected 16
Device, removal of (non-implant) 15
Mechanical Problem 15
Failure to Cut 14
Material Fragmentation 14
Packaging Problem 13
Manufacturing, Packaging or Shipping Problem 11
Component(s), broken 10
Use of Device Problem 10

Yearly Trend

92
1992: 3
93
1993: 2
94
1994: 7
95
1995: 6
96
1996: 2
97
1997: 4
98
1998: 5
99
1999: 4
00
2000: 5
01
2001: 5
02
2002: 16
03
2003: 15
04
2004: 20
05
2005: 22
06
2006: 27
07
2007: 28
08
2008: 10
09
2009: 18
10
2010: 9
11
2011: 19
12
2012: 35
13
2013: 125
14
2014: 67
15
2015: 45
16
2016: 45
17
2017: 73
18
2018: 80
19
2019: 53
20
2020: 35
21
2021: 35
22
2022: 21
23
2023: 28
24
2024: 33
25
2025: 40
26
2026: 28

Reports in 2025 (40) held close to the prior two-year average of 31.

Related Entities for Blade, Scalpel

Top Manufacturers

AESCULAP AG 37
BECTON DICKINSON 28
AESCULAP AG 26

Event Locations

492 (50.7%)
I 280 (28.9%)
HOSPITAL 154 (15.9%)
NO INFORMATION 15 (1.5%)
INVALID DATA 8 (0.8%)
OTHER 8 (0.8%)
AMBULATORY SURGICAL FACILITY 7 (0.7%)
OUTPATIENT TREATMENT FACILITY 5 (0.5%)
UNKNOWN 1 (0.1%)

Compare AESCULAP AG vs BECTON DICKINSON →

Nationwide devices with a comparable report-volume footprint

Blade, Scalpel carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (970 here).

Pump, Portable, Aspiration 968 Alarm, Conditioned Response Enuresis 965 Digital Breast Tomosynthesis 975 Percutaneously Delivered Prostheses And Tri… 965

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Blade, Scalpel 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 Blade, Scalpel; 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.