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2026 data FDA MAUDE openFDA

Kit, Surgical Instrument, Disposable

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 Kit, Surgical Instrument, Disposable LIGHT-BOOK · MAUDE

#853 of 1000 · 526 reports · 1992–2026

  • BOOK 526 reports
  • RANK #853 of 1000
  • DEATH 1 death-typed
  • INJ 131 injury-typed
  • MALF 343 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 63
  • PHOTO Snare, Non-Electrical

Nearest event-volume peer: Snare, Non-Electrical (1 report gap)

Kit, Surgical Instrument, Disposable sits #853 of 1000 among tracked device types with 526 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 24.9% corpus 30.4% · below corpus mean (-5.5 pp)
  • MALF 65.2% corpus 64.5% · above corpus mean (+0.7 pp)

Lead product-problem code Inadequate Lubrication is 31% of coded problems · Lead manufacturer MERIT MEDICAL SYSTEMS, INC. accounts for 68% of manufacturer-tagged reports · Top event location is 36% of location-tagged rows .

Kit, Surgical Instrument, Disposable in the event-volume neighbourhood

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

reports

What this shows Kit, Surgical Instrument, Disposable carries 526 MAUDE reports, ranked #853 of 1000.

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

Event Types

Malfunction 343 (65.2%)
Injury 131 (24.9%)
Other 46 (8.7%)
5 (1.0%)
Death 1 (0.2%)

Patient Outcomes

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

276 (49.9%)
Other 172 (31.1%)
Required Intervention 54 (9.8%)
R 18 (3.3%)
Hospitalization 15 (2.7%)
Life Threatening 7 (1.3%)
O 6 (1.1%)
S 2 (0.4%)
L 1 (0.2%)
Death 1 (0.2%)
Disability 1 (0.2%)

Top Product Problems

Inadequate Lubrication 92
Adverse Event Without Identified Device or Use Problem 46
Break 31
Device Damaged by Another Device 15
Contamination /Decontamination Problem 12
Material Integrity Problem 12
Device Contamination with Chemical or Other Material 10
Appropriate Term/Code Not Available 8
Output Problem 8
Contamination 7
Material Fragmentation 7
Delivered as Unsterile Product 6
Detachment of Device or Device Component 6
Device Operates Differently Than Expected 6
Fluid/Blood Leak 6
Leak/Splash 6
Electrical /Electronic Property Problem 5
Expiration Date Error 5
Failure To Adhere Or Bond 5
Improper or Incorrect Procedure or Method 5

Yearly Trend

92
1992: 1
95
1995: 5
98
1998: 1
00
2000: 2
01
2001: 7
02
2002: 19
03
2003: 6
05
2005: 1
10
2010: 3
11
2011: 8
12
2012: 5
13
2013: 44
14
2014: 25
15
2015: 54
16
2016: 33
17
2017: 12
18
2018: 17
19
2019: 22
20
2020: 44
21
2021: 63
22
2022: 12
23
2023: 43
24
2024: 58
25
2025: 33
26
2026: 8

Related Entities for Kit, Surgical Instrument, Disposable

Top Manufacturers

MERIT MEDICAL SYSTEMS, INC. 36
STRYKER ENDOSCOPY-SAN JOSE 17

Event Locations

190 (36.1%)
I 154 (29.3%)
HOSPITAL 128 (24.3%)
NO INFORMATION 50 (9.5%)
AMBULATORY SURGICAL FACILITY 2 (0.4%)
NOT APPLICABLE 2 (0.4%)

Compare MERIT MEDICAL SYSTEMS, INC. vs STRYKER ENDOSCOPY-SAN JOSE →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Kit, Surgical Instrument, Disposable, 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 (526 here).

Snare, Non-Electrical 527 Insufflator, Hysteroscopic 523 Table, Obstetric 523 Unit, X-Ray, Extraoral With Timer 521

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 Kit, Surgical Instrument, Disposable 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 Kit, Surgical Instrument, Disposable; 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.