PlainHospital
2026 data FDA MAUDE openFDA

Cutter, Surgical

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 Cutter, Surgical LIGHT-BOOK · MAUDE

#814 of 1000 · 593 reports · 1992–2026

  • BOOK 593 reports
  • RANK #814 of 1000
  • DEATH 0 death-typed
  • INJ 24 injury-typed
  • MALF 566 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 84
  • PHOTO Suture, Nonabsorbable

Nearest event-volume peer: Suture, Nonabsorbable (1 report gap)

Cutter, Surgical sits #814 of 1000 among tracked device types with 593 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 4.0% corpus 30.4% · below corpus mean (-26.4 pp)
  • MALF 95.4% corpus 64.5% · above corpus mean (+30.9 pp)

Lead product-problem code Degraded is 36% of coded problems · Lead manufacturer DEPUY MITEK LLC US accounts for 84% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Cutter, Surgical in the event-volume neighbourhood

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

reports

What this shows Cutter, Surgical carries 593 MAUDE reports, ranked #814 of 1000.

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

Event Types

Malfunction 566 (95.4%)
Injury 24 (4.0%)
Other 2 (0.3%)
1 (0.2%)

Patient Outcomes

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

551 (92.9%)
Other 21 (3.5%)
Required Intervention 15 (2.5%)
Hospitalization 2 (0.3%)
Life Threatening 2 (0.3%)
O 1 (0.2%)
R 1 (0.2%)

Top Product Problems

Degraded 195
Mechanical Jam 68
Break 66
Difficult to Open or Close 48
Use of Device Problem 39
Dull, Blunt 25
Material Deformation 20
Failure to Cut 13
Device-Device Incompatibility 11
Material Integrity Problem 11
Mechanical Problem 11
Appropriate Term/Code Not Available 6
Component Missing 6
Corroded 6
Device Operates Differently Than Expected 5
Material Twisted/Bent 5
No Apparent Adverse Event 4
Adverse Event Without Identified Device or Use Problem 3
Detachment of Device or Device Component 3
Failure to Fire 3

Yearly Trend

92
1992: 4
93
1993: 1
94
1994: 1
95
1995: 1
96
1996: 2
97
1997: 1
98
1998: 1
00
2000: 1
01
2001: 3
03
2003: 3
04
2004: 10
05
2005: 2
06
2006: 9
07
2007: 2
08
2008: 2
09
2009: 4
10
2010: 21
11
2011: 7
12
2012: 10
13
2013: 5
14
2014: 11
15
2015: 6
16
2016: 18
17
2017: 4
18
2018: 28
19
2019: 36
20
2020: 59
21
2021: 63
22
2022: 76
23
2023: 58
24
2024: 84
25
2025: 57
26
2026: 3

Related Entities for Cutter, Surgical

Top Manufacturers

DEPUY MITEK LLC US 399
MAQUET CARDIOVASCULAR LLC 21
MAQUET CV 16
SYNTHES GMBH 16
DEPUY MITEK 8
MAQUET CARDIOVASCULAR, LLC 8
THE ANSPACH EFFORT, INC. 5

Event Locations

351 (59.2%)
I 199 (33.6%)
HOSPITAL 37 (6.2%)
OTHER 4 (0.7%)
INVALID DATA 1 (0.2%)
NO INFORMATION 1 (0.2%)

Compare DEPUY MITEK LLC US vs MAQUET CARDIOVASCULAR LLC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Cutter, Surgical, 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 (593 here).

Suture, Nonabsorbable 592 Endoscope 596 Pacemaker, Cardiac, External Transcutaneous 597 Centrifuges For Clinical Use 588

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 Cutter, Surgical 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 Cutter, Surgical; 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.