Lithotriptor, Extracorporeal Shock-Wave, Urological
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 §876.5990 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Lithotriptor LIGHT-BOOK · MAUDE
#725 of 1000 · 811 reports · 1993–2026
- BOOK 811 reports
- RANK #725 of 1000
- DEATH 30 death-typed
- INJ 569 injury-typed
- MALF 171 malfunction
- SPAN 1993–2026
- PEAK 2023: 86
- PHOTO Catheter, Nephrostomy
Nearest event-volume peer: Catheter, Nephrostomy (1 report gap)
Lithotriptor, Extracorporeal Shock-Wave, Urological sits #725 of 1000 among tracked device types with 811 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 → · Similar-volume device →
Malfunction reports sit below the device-type norm
Lithotriptor carries 21.1% MALFUNCTION-coded reports, 43.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 3.7% corpus 1.5% · above corpus mean (+2.2 pp)
- INJ 70.2% corpus 30.3% · above corpus mean (+39.9 pp)
- MALF 21.1% corpus 64.8% · below corpus mean (-43.7 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 68% of coded problems · Top event location is 45% of location-tagged rows .
Lithotriptor in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Applicator
Applicator, Absorbent Tipped, Sterile
813 reports
- Catheter
Catheter, Nephrostomy
812 reports
- Lithotriptor (this)
Lithotriptor, Extracorporeal Shock-Wave, Urological
811 reports
- Respiratory V…
Respiratory Virus Panel Nucleic Acid Assay System
808 reports
- Unit
Unit, Neonatal Phototherapy
808 reports
- Cannula
Cannula, Ophthalmic
807 reports
What this shows Lithotriptor, Extracorporeal Shock-Wave, Urological carries 811 MAUDE reports, ranked #725 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 in 2025 (61) held close to the prior two-year average of 63.
Related Entities for Lithotriptor, Extracorporeal Shock-Wave, Urological
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Lithotriptor: 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 (811 here).
Similar death-typed counts
Nearest other device types by death-typed report count (30 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Lithotriptor 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; 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.