2026 data FDA MAUDE openFDA FDA Class I

Instrument, Surgical, 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).

FDA MAUDE casebook

openFDA event book Instrument, Surgical, Disposable LIGHT-BOOK · MAUDE

#705 of 1000 · 866 reports · 1993–2026

  • BOOK 866 reports
  • RANK #705 of 1000
  • DEATH 2 death-typed
  • INJ 147 injury-typed
  • MALF 702 malfunction
  • SPAN 1993–2026
  • PEAK 2013: 538
  • PHOTO Electrocardiograph

Nearest event-volume peer: Electrocardiograph (2 report gap)

Instrument, Surgical, Disposable sits #705 of 1000 among tracked device types with 866 MAUDE reports spanning 1993–2026. 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 →

Malfunction reports run above the device-type norm

Instrument, Surgical, Disposable carries 81.1% MALFUNCTION-coded reports, 16.2pp above 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 17.0% corpus 30.3% · below corpus mean (-13.3 pp)
  • MALF 81.1% corpus 64.8% · above corpus mean (+16.2 pp)

Lead product-problem code Device Contamination with Chemical or Other Material is 23% of coded problems · Lead manufacturer DEPUY SYNTHES POWER TOOLS accounts for 46% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .

Instrument, Surgical, Disposable in the event-volume neighbourhood

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

reports

What this shows Instrument, Surgical, Disposable carries 866 MAUDE reports, ranked #705 of 1000.

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

Event Types

Malfunction 702 (81.1%)
Injury 147 (17.0%)
12 (1.4%)
Other 3 (0.3%)
Death 2 (0.2%)

Patient Outcomes

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

684 (77.7%)
Required Intervention 109 (12.4%)
Other 35 (4.0%)
Hospitalization 29 (3.3%)
R 11 (1.3%)
L 3 (0.3%)
Invalid Data 3 (0.3%)
Death 2 (0.2%)
H 1 (0.1%)
O 1 (0.1%)
S 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Device Contamination with Chemical or Other Material 223
Device Packaging Compromised 166
Packaging Problem 97
Break 76
Adverse Event Without Identified Device or Use Problem 74
Device Contaminated During Manufacture or Shipping 55
Device Operates Differently Than Expected 54
Delivered as Unsterile Product 51
Material Separation 43
Residue After Decontamination 32
Out-Of-Box Failure 16
Device Reprocessing Problem 15
Device Disinfection Or Sterilization Issue 13
Manufacturing, Packaging or Shipping Problem 13
Product Quality Problem 12
Trocar failure 12
Disconnection 11
Metal Shedding Debris 11
Dull, Blunt 7
Fluid/Blood Leak 7

Yearly Trend

93
1993: 12
94
1994: 38
95
1995: 7
05
2005: 2
07
2007: 2
08
2008: 7
10
2010: 9
11
2011: 6
12
2012: 12
13
2013: 538
14
2014: 17
15
2015: 15
16
2016: 11
17
2017: 9
18
2018: 71
19
2019: 16
20
2020: 13
21
2021: 11
22
2022: 10
23
2023: 15
24
2024: 14
25
2025: 7
26
2026: 24

Reports fell to 7 in 2025, down from an average of 15 in the two years before.

Related Entities for Instrument, Surgical, Disposable

Event Locations

663 (76.6%)
I 121 (14.0%)
HOSPITAL 60 (6.9%)
INVALID DATA 14 (1.6%)
NO INFORMATION 6 (0.7%)
OTHER 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare DEPUY SYNTHES POWER TOOLS vs THE ANSPACH EFFORT, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Instrument, Surgical, 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 (866 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Instrument, Surgical, 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 Instrument, Surgical, 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.