2026 data FDA MAUDE openFDA

Lithotriptor, Biliary Mechanical

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 MAUDE casebook

openFDA event book Lithotriptor, Biliary Mechanical LIGHT-BOOK · MAUDE

#417 of 1000 · 2,772 reports · 1996–2026

  • BOOK 2,772 reports
  • RANK #417 of 1000
  • DEATH 11 death-typed
  • INJ 634 injury-typed
  • MALF 2,105 malfunction
  • SPAN 1996–2026
  • PEAK 2024: 301
  • PHOTO Stent

Nearest event-volume peer: Stent, Superficial Femoral Artery, Drug-Eluting (18 report gap)

Lithotriptor, Biliary Mechanical sits #417 of 1000 among tracked device types with 2,772 MAUDE reports spanning 1996–2026. 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 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 22.9% corpus 30.4% · below corpus mean (-7.6 pp)
  • MALF 75.9% corpus 64.5% · above corpus mean (+11.4 pp)

Lead product-problem code Break is 41% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 39% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

Lithotriptor, Biliary Mechanical in the event-volume neighbourhood

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

reports

What this shows Lithotriptor, Biliary Mechanical carries 2,772 MAUDE reports, ranked #417 of 1000.

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

Event Types

Malfunction 2,105 (75.9%)
Injury 634 (22.9%)
Other 17 (0.6%)
Death 11 (0.4%)
5 (0.2%)

Patient Outcomes

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

2,060 (70.8%)
Required Intervention 477 (16.4%)
Other 119 (4.1%)
Hospitalization 102 (3.5%)
R 100 (3.4%)
O 17 (0.6%)
H 15 (0.5%)
Death 8 (0.3%)
D 4 (0.1%)
L 3 (0.1%)
Disability 2 (0.1%)
Life Threatening 2 (0.1%)
S 1 (0.0%)

Top Product Problems

Break 888
Material Deformation 262
Detachment of Device or Device Component 177
Material Split, Cut or Torn 157
Adverse Event Without Identified Device or Use Problem 123
Separation Failure 122
Difficult to Open or Close 106
Difficult to Remove 76
Use of Device Problem 70
Premature Activation 47
Device Handling Problem 26
Material Twisted/Bent 23
Mechanical Problem 18
Deformation Due to Compressive Stress 16
Defective Device 12
Entrapment of Device 12
Crack 11
Mechanical Jam 10
Detachment Of Device Component 9
Device Operates Differently Than Expected 8

Yearly Trend

96
1996: 5
97
1997: 2
98
1998: 10
99
1999: 4
00
2000: 16
01
2001: 7
02
2002: 10
03
2003: 3
04
2004: 24
05
2005: 31
06
2006: 40
07
2007: 40
08
2008: 124
09
2009: 141
10
2010: 116
11
2011: 112
12
2012: 64
13
2013: 85
14
2014: 98
15
2015: 137
16
2016: 157
17
2017: 145
18
2018: 84
19
2019: 123
20
2020: 164
21
2021: 112
22
2022: 245
23
2023: 224
24
2024: 301
25
2025: 127
26
2026: 21

Related Entities for Lithotriptor, Biliary Mechanical

Event Locations

1,856 (67.0%)
I 805 (29.0%)
HOSPITAL 100 (3.6%)
NO INFORMATION 8 (0.3%)
INVALID DATA 2 (0.1%)
NOT APPLICABLE 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - SPENCER →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Lithotriptor, Biliary Mechanical, 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 (2,772 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Disclaimer: MAUDE figures for Lithotriptor, Biliary Mechanical 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 Lithotriptor, Biliary Mechanical; 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.