2026 data FDA MAUDE openFDA FDA Class I

Motor, Surgical Instrument, Pneumatic Powered

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 §878.4820 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Motor LIGHT-BOOK · MAUDE

#657 of 1000 · 1,030 reports · 1997–2026

  • BOOK 1,030 reports
  • RANK #657 of 1000
  • DEATH 1 death-typed
  • INJ 60 injury-typed
  • MALF 939 malfunction
  • SPAN 1997–2026
  • PEAK 2011: 280
  • PHOTO Restraint, Protective

Nearest event-volume peer: Restraint, Protective (3 report gap)

Motor, Surgical Instrument, Pneumatic Powered sits #657 of 1000 among tracked device types with 1,030 MAUDE reports spanning 1997–2026. 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

Motor carries 91.2% MALFUNCTION-coded reports, 26.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 5.8% corpus 30.3% · below corpus mean (-24.5 pp)
  • MALF 91.2% corpus 64.8% · above corpus mean (+26.3 pp)

Lead product-problem code Heat is 16% of coded problems · Lead manufacturer STRYKER INSTRUMENTS KALAMAZOO accounts for 61% of manufacturer-tagged reports · Top event location is 81% of location-tagged rows .

Motor in the event-volume neighbourhood

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

reports

What this shows Motor, Surgical Instrument, Pneumatic Powered carries 1,030 MAUDE reports, ranked #657 of 1000.

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

Event Types

Malfunction 939 (91.2%)
Injury 60 (5.8%)
Other 29 (2.8%)
1 (0.1%)
Death 1 (0.1%)

Patient Outcomes

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

917 (88.3%)
Other 81 (7.8%)
Required Intervention 23 (2.2%)
O 6 (0.6%)
Hospitalization 6 (0.6%)
L 1 (0.1%)
R 1 (0.1%)
S 1 (0.1%)
Death 1 (0.1%)
Disability 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Heat 161
Break 147
Overheating of Device 108
Device Slipped 97
Failure to Align 83
Detachment Of Device Component 47
Difficult to Open or Close 46
Sticking 46
Mechanical Jam 29
Component Falling 28
Component(s), broken 26
Detachment of Device or Device Component 23
Mechanical Problem 21
Other (for use when an appropriate device code cannot be identified) 21
Peeled/Delaminated 20
Device Operates Differently Than Expected 18
Replace 18
Sterility 18
Torn Material 18
Burst Container or Vessel 16

Yearly Trend

97
1997: 1
99
1999: 12
00
2000: 53
01
2001: 47
02
2002: 54
03
2003: 28
04
2004: 7
05
2005: 25
06
2006: 60
07
2007: 33
08
2008: 8
09
2009: 11
10
2010: 35
11
2011: 280
12
2012: 48
13
2013: 34
14
2014: 26
15
2015: 43
16
2016: 29
17
2017: 45
18
2018: 46
19
2019: 15
20
2020: 15
21
2021: 9
22
2022: 13
23
2023: 6
24
2024: 19
25
2025: 8
26
2026: 20

Reports fell to 8 in 2025, down from an average of 13 in the two years before.

Related Entities for Motor, Surgical Instrument, Pneumatic Powered

Event Locations

837 (81.3%)
I 174 (16.9%)
HOSPITAL 12 (1.2%)
NO INFORMATION 6 (0.6%)
NOT APPLICABLE 1 (0.1%)

Compare STRYKER INSTRUMENTS KALAMAZOO vs US SURGICAL PUERTO RICO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Motor: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Disclaimer: MAUDE figures for Motor 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 Motor; 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.