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2026 data FDA MAUDE openFDA FDA Class I

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.

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 Kit, Surgical Instrument, Disposable LIGHT-BOOK · MAUDE

#860 of 1000 · 550 reports · 1992–2026

  • BOOK 550 reports
  • RANK #860 of 1000
  • DEATH 1 death-typed
  • INJ 131 injury-typed
  • MALF 367 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 63
  • PHOTO Applicator

Nearest event-volume peer: Applicator, Absorbent Tipped, Non-Sterile (2 report gap)

Kit, Surgical Instrument, Disposable sits #860 of 1000 among tracked device types with 550 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

Kit, Surgical Instrument, Disposable carries 23.8% INJURY-coded reports, 6.5pp 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 23.8% corpus 30.3% · below corpus mean (-6.5 pp)
  • MALF 66.7% corpus 64.8% · above corpus mean (+1.9 pp)

Lead product-problem code Inadequate Lubrication is 23% of coded problems · Lead manufacturer MERIT MEDICAL SYSTEMS, INC. accounts for 67% of manufacturer-tagged reports · Top event location is 38% 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 550 MAUDE reports, ranked #860 of 1000.

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

Event Types

Malfunction 367 (66.7%)
Injury 131 (23.8%)
Other 46 (8.4%)
5 (0.9%)
Death 1 (0.2%)

Patient Outcomes

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

288 (50.3%)
Other 180 (31.4%)
Required Intervention 54 (9.4%)
R 18 (3.1%)
Hospitalization 15 (2.6%)
Life Threatening 7 (1.2%)
O 6 (1.0%)
S 2 (0.3%)
L 1 (0.2%)
Death 1 (0.2%)
Disability 1 (0.2%)

Top Product Problems

Inadequate Lubrication 100
Adverse Event Without Identified Device or Use Problem 48
Break 40
Delivered as Unsterile Product 33
Material Integrity Problem 22
Device Contamination with Chemical or Other Material 20
Packaging Problem 18
Fluid/Blood Leak 17
Device Damaged by Another Device 15
Appropriate Device Problem Term/Code Not Available 14
Leak/Splash 14
Material Fragmentation 13
Contamination /Decontamination Problem 12
Detachment Of Device Component 12
Device Operates Differently Than Expected 12
Flaked 8
Output Problem 8
Contamination 7
Device Contaminated During Manufacture or Shipping 7
Mechanical Problem 7

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: 34
26
2026: 31

Reports in 2025 (34) held close to the prior two-year average of 51.

Related Entities for Kit, Surgical Instrument, Disposable

Top Manufacturers

MERIT MEDICAL SYSTEMS, INC. 36
STRYKER ENDOSCOPY-SAN JOSE 18

Event Locations

211 (38.4%)
I 154 (28.0%)
HOSPITAL 129 (23.5%)
NO INFORMATION 50 (9.1%)
AMBULATORY SURGICAL FACILITY 4 (0.7%)
NOT APPLICABLE 2 (0.4%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Kit, Surgical Instrument, Disposable: 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 (550 here).

Applicator, Absorbent Tipped, Non-Sterile 552 Cup, Menstrual 553 Method, Enzymatic, Glucose 547 Chair, Positioning, Electric 554

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.