PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

System, Surgical, Computer Controlled Instrument

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 II (moderate risk, special controls required), regulated under 21 CFR §876.1500 (Gastroenterology, Urology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book System HEAVY-BOOK · MAUDE

#31 of 1000 · 137,980 reports · 2000–2026

  • BOOK 137,980 reports
  • RANK #31 of 1000
  • DEATH 777 death-typed
  • INJ 10,886 injury-typed
  • MALF 125,183 malfunction
  • SPAN 2000–2026
  • PEAK 2025: 49,306
  • PHOTO Permanent Defibrillat…

Nearest event-volume peer: Permanent Defibrillator Electrodes (260 report gap)

System, Surgical, Computer Controlled Instrument sits #31 of 1000 among tracked device types with 137,980 MAUDE reports spanning 2000–2026. 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

System carries 90.7% MALFUNCTION-coded reports, 25.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 7.9% corpus 30.3% · below corpus mean (-22.4 pp)
  • MALF 90.7% corpus 64.8% · above corpus mean (+25.9 pp)

Lead product-problem code Material Split, Cut or Torn is 34% of coded problems · Lead manufacturer INTUITIVE SURGICAL, INC accounts for 84% of manufacturer-tagged reports · Top event location is 82% of location-tagged rows .

System in the event-volume neighbourhood

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

reports

What this shows System, Surgical, Computer Controlled Instrument carries 137,980 MAUDE reports, ranked #31 of 1000.

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

Event Types

Malfunction 125,183 (90.7%)
Injury 10,886 (7.9%)
Other 1,044 (0.8%)
Death 777 (0.6%)
90 (0.1%)

Patient Outcomes

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

122,965 (92.6%)
Required Intervention 4,877 (3.7%)
Other 1,993 (1.5%)
R 950 (0.7%)
Hospitalization 724 (0.5%)
Death 493 (0.4%)
H 265 (0.2%)
L 218 (0.2%)
Life Threatening 103 (0.1%)
O 62 (0.0%)
S 60 (0.0%)
D 55 (0.0%)
Disability 24 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Material Split, Cut or Torn 43,378
Break 14,366
Material Frayed 10,650
Material Fragmentation 7,964
Detachment of Device or Device Component 7,001
Visual Prompts will not Clear 6,822
Difficult to Open or Close 6,199
Output Problem 4,577
Unintended System Motion 2,770
Thermal Decomposition of Device 2,670
Adverse Event Without Identified Device or Use Problem 2,638
Unintended Movement 2,628
No Apparent Adverse Event 2,544
No Device Output 1,960
Device Operates Differently Than Expected 1,907
Arcing 1,674
Insufficient Device Problem Information 1,554
Energy Output Problem 1,525
Failure to Deliver Energy 1,516
Device Displays Incorrect Message 1,437

Yearly Trend

00
2000: 1
01
2001: 42
02
2002: 82
03
2003: 55
04
2004: 76
05
2005: 55
06
2006: 23
07
2007: 133
08
2008: 224
09
2009: 381
10
2010: 623
11
2011: 501
12
2012: 1,552
13
2013: 6,217
14
2014: 6,135
15
2015: 1,722
16
2016: 1,077
17
2017: 1,049
18
2018: 1,074
19
2019: 1,154
20
2020: 1,558
21
2021: 1,997
22
2022: 5,727
23
2023: 10,898
24
2024: 12,872
25
2025: 49,306
26
2026: 33,446

Reports rose to 49,306 in 2025, up from an average of 11,885 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for System, Surgical, Computer Controlled Instrument

Top Manufacturers

INTUITIVE SURGICAL, INC 115,112
INTUITIVE SURGICAL,INC. 17,596
INTUITIVE SURGICAL, INC. 4,177
INTUITIVE SURGICAL INC. 210
INTUITIVE SURGICAL INC 73
UNK 22

Event Locations

113,450 (82.2%)
HOSPITAL 18,814 (13.6%)
I 5,111 (3.7%)
NO INFORMATION 589 (0.4%)
OTHER 10 (0.0%)
OPERATING ROOM 3 (0.0%)
UNKNOWN 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare INTUITIVE SURGICAL, INC vs INTUITIVE SURGICAL,INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System: 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 (137,980 here).

Permanent Defibrillator Electrodes 137,720 Prosthesis, Hip, Semi-Constrained 138,399 Coronary Drug-Eluting Stent 128,715 Wearable Automated External Defibrillator 148,775

Similar death-typed counts

Nearest other device types by death-typed report count (777 here), distinct from the volume row.

Set, Administration, Intravascular 779 Ring, Annuloplasty 780 Device, Hemostasis, Vascular 741 Stimulator 729

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for System 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 System; 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.