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2026 data FDA MAUDE openFDA

Powered Laser Surgical 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 Powered Laser Surgical Instrument MID-BOOK · MAUDE

#77 of 1000 · 42,730 reports · 1992–2026

  • BOOK 42,730 reports
  • RANK #77 of 1000
  • DEATH 104 death-typed
  • INJ 8,496 injury-typed
  • MALF 33,380 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 3,525
  • PHOTO Catheters

Nearest event-volume peer: Catheters, Transluminal Coronary Angioplasty, Percutaneous (195 report gap)

Powered Laser Surgical Instrument sits #77 of 1000 among tracked device types with 42,730 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 →

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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 19.9% corpus 30.4% · below corpus mean (-10.6 pp)
  • MALF 78.1% corpus 64.5% · above corpus mean (+13.6 pp)

Lead product-problem code Break is 21% of coded problems · Lead manufacturer AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) accounts for 32% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Powered Laser Surgical Instrument in the event-volume neighbourhood

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

reports

What this shows Powered Laser Surgical Instrument carries 42,730 MAUDE reports, ranked #77 of 1000.

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

Event Types

Malfunction 33,380 (78.1%)
Injury 8,496 (19.9%)
Other 556 (1.3%)
170 (0.4%)
Death 104 (0.2%)
No answer provided 24 (0.1%)

Patient Outcomes

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

28,912 (66.2%)
Other 9,876 (22.6%)
Required Intervention 3,113 (7.1%)
R 580 (1.3%)
Hospitalization 352 (0.8%)
Disability 276 (0.6%)
O 177 (0.4%)
S 127 (0.3%)
Death 106 (0.2%)
H 75 (0.2%)
L 36 (0.1%)
Life Threatening 33 (0.1%)
Congenital Anomaly 7 (0.0%)
D 4 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Break 5,791
Adverse Event Without Identified Device or Use Problem 4,055
Fracture 3,518
Temperature Problem 2,544
Appropriate Term/Code Not Available 1,621
Decrease in Suction 1,489
Detachment of Device or Device Component 1,074
Defective Device 904
Device Displays Incorrect Message 766
Firing Problem 678
Device Operates Differently Than Expected 667
Insufficient Information 591
Failure to Align 548
Overheating of Device 517
Therapeutic or Diagnostic Output Failure 460
Device Operational Issue 424
Output Problem 420
Suction Problem 411
Unexpected Therapeutic Results 398
Output below Specifications 366

Yearly Trend

92
1992: 8
93
1993: 7
94
1994: 30
95
1995: 18
96
1996: 41
97
1997: 91
98
1998: 74
99
1999: 73
00
2000: 79
01
2001: 61
02
2002: 82
03
2003: 88
04
2004: 89
05
2005: 214
06
2006: 309
07
2007: 342
08
2008: 232
09
2009: 209
10
2010: 1,711
11
2011: 3,024
12
2012: 2,000
13
2013: 2,236
14
2014: 2,036
15
2015: 2,099
16
2016: 2,584
17
2017: 2,975
18
2018: 3,525
19
2019: 2,709
20
2020: 2,183
21
2021: 3,465
22
2022: 2,288
23
2023: 2,337
24
2024: 2,251
25
2025: 2,831
26
2026: 429

Related Entities for Powered Laser Surgical Instrument

Top Manufacturers

AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 5,948
BOSTON SCIENTIFIC CORPORATION 5,549
WAVELIGHT GMBH 4,073
AMERICAN MEDICAL SYSTEMS, INC. 1,705
BOSTON SCIENTIFIC - MARLBOROUGH 1,266

Event Locations

23,291 (54.5%)
I 16,745 (39.2%)
HOSPITAL 1,012 (2.4%)
NO INFORMATION 675 (1.6%)
OTHER 358 (0.8%)
OUTPATIENT TREATMENT FACILITY 351 (0.8%)
NOT APPLICABLE 98 (0.2%)
UNKNOWN 83 (0.2%)
INVALID DATA 53 (0.1%)
AMBULATORY SURGICAL FACILITY 40 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 9 (0.0%)
HOME 8 (0.0%)
PUBLIC VENUE 4 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)
NURSING HOME 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Powered Laser Surgical Instrument, 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 (42,730 here).

Catheters 42,925 Dialyzer 42,530 Neurological Stereotaxic Instrument 42,097 Stimulator, Spinal-Cord, Implanted 43,829

Similar death-typed counts

Nearest other device types by death-typed report count (104 here), distinct from the volume row.

Stent, Colonic, Metallic, Expandable 104 Separator 105 Stretcher, Wheeled 102 Gas-Machine, Anesthesia 107

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

Disclaimer: MAUDE figures for Powered Laser Surgical Instrument 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 Powered Laser Surgical Instrument; 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.