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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book System HEAVY-BOOK · MAUDE

#34 of 1000 · 118,454 reports · 2000–2026

  • BOOK 118,454 reports
  • RANK #34 of 1000
  • DEATH 732 death-typed
  • INJ 9,994 injury-typed
  • MALF 106,601 malfunction
  • SPAN 2000–2026
  • PEAK 2025: 49,306
  • PHOTO Device

Nearest event-volume peer: Device, Hemostasis, Vascular (2,837 report gap)

System, Surgical, Computer Controlled Instrument sits #34 of 1000 among tracked device types with 118,454 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 →

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 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 8.4% corpus 30.4% · below corpus mean (-22.0 pp)
  • MALF 90.0% corpus 64.5% · above corpus mean (+25.5 pp)

Lead product-problem code Material Split, Cut or Torn is 39% of coded problems · Lead manufacturer INTUITIVE SURGICAL, INC accounts for 81% of manufacturer-tagged reports · Top event location is 79% 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 118,454 MAUDE reports, ranked #34 of 1000.

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

Event Types

Malfunction 106,601 (90.0%)
Injury 9,994 (8.4%)
Other 1,037 (0.9%)
Death 732 (0.6%)
90 (0.1%)

Patient Outcomes

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

110,022 (92.4%)
Required Intervention 4,418 (3.7%)
Other 1,816 (1.5%)
R 886 (0.7%)
Hospitalization 685 (0.6%)
Death 463 (0.4%)
H 224 (0.2%)
L 216 (0.2%)
Life Threatening 95 (0.1%)
O 60 (0.1%)
S 59 (0.0%)
D 41 (0.0%)
Disability 24 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Material Split, Cut or Torn 36,935
Material Fragmentation 7,598
Material Frayed 7,506
Break 6,917
Detachment of Device or Device Component 6,399
Difficult to Open or Close 5,011
Visual Prompts will not Clear 4,626
Output Problem 2,716
Thermal Decomposition of Device 2,325
Unintended System Motion 2,304
Unintended Movement 2,037
Adverse Event Without Identified Device or Use Problem 1,984
No Apparent Adverse Event 1,960
No Device Output 1,490
Failure to Deliver Energy 1,437
Energy Output Problem 1,255
Arcing 1,163
Insufficient Information 710
Device Displays Incorrect Message 655
Difficult to Remove 647

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: 380
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: 13,921

Related Entities for System, Surgical, Computer Controlled Instrument

Top Manufacturers

INTUITIVE SURGICAL, INC 95,771
INTUITIVE SURGICAL,INC. 17,596
INTUITIVE SURGICAL, INC. 4,017
INTUITIVE SURGICAL INC. 197
INTUITIVE SURGICAL INC 71
UNK 21

Event Locations

94,040 (79.4%)
HOSPITAL 18,698 (15.8%)
I 5,111 (4.3%)
NO INFORMATION 589 (0.5%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for System, 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 (118,454 here).

Device, Hemostasis, Vascular 121,291 Sensor 114,527 Electrosurgical 114,517 Pump, Infusion, Implanted, Programmable 114,088

Similar death-typed counts

Nearest other device types by death-typed report count (732 here), distinct from the volume row.

Stimulator 712 Cardiac Ablation Percutaneous Catheter 710 Ring, Annuloplasty 777 Stent, Carotid 681

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.