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2026 data FDA MAUDE openFDA FDA Class II

Lithotriptor, Electro-Hydraulic

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 §876.4480 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Lithotriptor, Electro-Hydraulic LIGHT-BOOK · MAUDE

#937 of 1000 · 438 reports · 1993–2026

  • BOOK 438 reports
  • RANK #937 of 1000
  • DEATH 9 death-typed
  • INJ 114 injury-typed
  • MALF 290 malfunction
  • SPAN 1993–2026
  • PEAK 2020: 39
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief (0 report gap)

Lithotriptor, Electro-Hydraulic sits #937 of 1000 among tracked device types with 438 MAUDE reports spanning 1993–2026. 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 →

Injury-coded reports sit below the device-type norm

Lithotriptor, Electro-Hydraulic carries 26.0% INJURY-coded reports, 4.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.1% corpus 1.5% · above corpus mean (+0.5 pp)
  • INJ 26.0% corpus 30.3% · below corpus mean (-4.3 pp)
  • MALF 66.2% corpus 64.8% · above corpus mean (+1.4 pp)

Lead product-problem code Break is 23% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 35% of manufacturer-tagged reports · Top event location is 40% of location-tagged rows .

Lithotriptor, Electro-Hydraulic in the event-volume neighbourhood

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

reports

What this shows Lithotriptor, Electro-Hydraulic carries 438 MAUDE reports, ranked #937 of 1000.

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

Event Types

Malfunction 290 (66.2%)
Injury 114 (26.0%)
Other 17 (3.9%)
Death 9 (2.1%)
8 (1.8%)

Patient Outcomes

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

281 (61.0%)
Other 62 (13.4%)
Required Intervention 58 (12.6%)
Hospitalization 23 (5.0%)
R 11 (2.4%)
Death 9 (2.0%)
O 7 (1.5%)
L 3 (0.7%)
Life Threatening 3 (0.7%)
Disability 2 (0.4%)
H 1 (0.2%)
Invalid Data 1 (0.2%)

Top Product Problems

Break 85
Tip breakage 46
Fracture 24
Detachment Of Device Component 23
Output Problem 16
Unknown (for use when the device problem is not known) 16
Adverse Event Without Identified Device or Use Problem 14
No Device Output 14
Replace 14
Detachment of Device or Device Component 13
Device, or device fragments remain in patient 11
Insufficient Device Problem Information 11
Material Separation 11
Metal Shedding Debris 11
Overheating of Device 11
Probe failure 11
Component(s), broken 10
Device Issue 10
Shock, electrical 9
Device Inoperable 7

Yearly Trend

93
1993: 2
94
1994: 13
95
1995: 4
96
1996: 17
97
1997: 35
98
1998: 30
99
1999: 10
00
2000: 11
01
2001: 11
02
2002: 9
03
2003: 11
04
2004: 3
05
2005: 8
06
2006: 19
07
2007: 6
08
2008: 12
09
2009: 35
10
2010: 16
11
2011: 6
12
2012: 2
13
2013: 10
14
2014: 9
15
2015: 7
16
2016: 7
17
2017: 9
18
2018: 18
19
2019: 10
20
2020: 39
21
2021: 22
22
2022: 13
23
2023: 10
24
2024: 8
25
2025: 6
26
2026: 10

Reports in 2025 (6) held close to the prior two-year average of 9.

Related Entities for Lithotriptor, Electro-Hydraulic

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 39
GYRUS ACMI INC 35
BOSTON SCIENTIFIC - SPENCER 26
BOSTON SCIENTIFIC 13

Event Locations

177 (40.4%)
HOSPITAL 147 (33.6%)
I 86 (19.6%)
INVALID DATA 10 (2.3%)
NO INFORMATION 7 (1.6%)
UNKNOWN 5 (1.1%)
OTHER 3 (0.7%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare BOSTON SCIENTIFIC CORPORATION vs GYRUS ACMI INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Lithotriptor, Electro-Hydraulic: 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 (438 here).

Stimulator 438 Implanted Fecal Incontinence Device 436 Inhibitor, Peridural Fibrosis 440 Resectoscope, Working Element 440

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

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

Disclaimer: MAUDE figures for Lithotriptor, Electro-Hydraulic 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, Electro-Hydraulic; 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.