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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Blade, Scalpel LIGHT-BOOK · MAUDE

#670 of 1000 · 954 reports · 1992–2026

  • BOOK 954 reports
  • RANK #670 of 1000
  • DEATH 0 death-typed
  • INJ 238 injury-typed
  • MALF 659 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 #670 of 1000 among tracked device types with 954 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 →

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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 24.9% corpus 30.4% · below corpus mean (-5.5 pp)
  • MALF 69.1% corpus 64.5% · above corpus mean (+4.6 pp)

Lead product-problem code Break is 49% of coded problems · Lead manufacturer AESCULAP AG accounts for 41% of manufacturer-tagged reports · Top event location is 50% 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 954 MAUDE reports, ranked #670 of 1000.

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

Event Types

Malfunction 659 (69.1%)
Injury 238 (24.9%)
Other 44 (4.6%)
13 (1.4%)

Patient Outcomes

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

568 (54.6%)
Other 232 (22.3%)
Required Intervention 139 (13.4%)
R 79 (7.6%)
Hospitalization 13 (1.3%)
O 3 (0.3%)
L 2 (0.2%)
S 2 (0.2%)
H 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 219
Tear, Rip or Hole in Device Packaging 31
Dull, Blunt 30
Material Integrity Problem 20
Insufficient Information 19
Unsealed Device Packaging 18
Fracture 16
Failure to Cut 13
Mechanical Problem 13
Detachment Of Device Component 10
Device Operates Differently Than Expected 7
Adverse Event Without Identified Device or Use Problem 6
Corroded 6
Delivered as Unsterile Product 6
Manufacturing, Packaging or Shipping Problem 6
Material Fragmentation 6
Packaging Problem 6
Detachment of Device or Device Component 5
Difficult to Remove 5
Component Falling 4

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: 39
26
2026: 13

Related Entities for Blade, Scalpel

Top Manufacturers

AESCULAP AG 37
BECTON DICKINSON 28
AESCULAP AG 26

Event Locations

477 (50.0%)
I 280 (29.4%)
HOSPITAL 153 (16.0%)
NO INFORMATION 15 (1.6%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Blade, Scalpel, 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 (954 here).

Pump, Portable, Aspiration 956 Material, Tooth Shade, Resin 961 Alarm, Conditioned Response Enuresis 965 Midline Catheter 939

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.