Lithotriptor, Ultrasonic
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).
FDA MAUDE casebook
openFDA event book Lithotriptor, Ultrasonic LIGHT-BOOK · MAUDE
#622 of 1000 · 1,213 reports · 1994–2026
- BOOK 1,213 reports
- RANK #622 of 1000
- DEATH 4 death-typed
- INJ 44 injury-typed
- MALF 1,154 malfunction
- SPAN 1994–2026
- PEAK 2025: 356
- PHOTO Surgical Film
Nearest event-volume peer: Surgical Film (0 report gap)
Lithotriptor, Ultrasonic sits #622 of 1000 among tracked device types with 1,213 MAUDE reports spanning 1994–2026. 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
Lithotriptor, Ultrasonic carries 95.1% MALFUNCTION-coded reports, 30.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
- INJ 3.6% corpus 30.3% · below corpus mean (-26.7 pp)
- MALF 95.1% corpus 64.8% · above corpus mean (+30.3 pp)
Lead product-problem code Break is 26% of coded problems · Lead manufacturer GYRUS ACMI, INC. accounts for 79% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .
Lithotriptor, Ultrasonic in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Accessories
Accessories, Blood Circuit, Hemodialysis
1,220 reports
- Hemodialyzer
Hemodialyzer, Re-Use, High Flux
1,219 reports
- System
System, X-Ray, Stationary
1,218 reports
- Lithotriptor (this)
Lithotriptor, Ultrasonic
1,213 reports
- Surgical Film
Surgical Film
1,213 reports
- Stretcher
Stretcher, Hand-Carried
1,212 reports
What this shows Lithotriptor, Ultrasonic carries 1,213 MAUDE reports, ranked #622 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 356 in 2025, up from an average of 130 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Lithotriptor, Ultrasonic
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Lithotriptor, Ultrasonic: 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 (1,213 here).
Similar death-typed counts
Nearest other device types by death-typed report count (4 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Lithotriptor, Ultrasonic 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, Ultrasonic; 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.