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 Class II (moderate risk, special controls required), regulated under 21 CFR §876.4500 (Gastroenterology, Urology panel).
FDA MAUDE casebook
openFDA event book Lithotriptor, Biliary Mechanical LIGHT-BOOK · MAUDE
#419 of 1000 · 2,875 reports · 1996–2026
- BOOK 2,875 reports
- RANK #419 of 1000
- DEATH 12 death-typed
- INJ 664 injury-typed
- MALF 2,177 malfunction
- SPAN 1996–2026
- PEAK 2024: 301
- PHOTO Pin, Fixation, Smooth
Nearest event-volume peer: Pin, Fixation, Smooth (7 report gap)
Lithotriptor, Biliary Mechanical sits #419 of 1000 among tracked device types with 2,875 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 →
Malfunction reports run above the device-type norm
Lithotriptor, Biliary Mechanical carries 75.7% MALFUNCTION-coded reports, 10.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
- INJ 23.1% corpus 30.3% · below corpus mean (-7.2 pp)
- MALF 75.7% corpus 64.8% · above corpus mean (+10.9 pp)
Lead product-problem code Break is 37% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 41% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .
Lithotriptor, Biliary Mechanical in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Spinous Process Spacer/Plate
2,908 reports
- Lithotriptor (this)
Lithotriptor, Biliary Mechanical
2,875 reports
- Pin
Pin, Fixation, Smooth
2,868 reports
- Instrument
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
2,859 reports
- Nebulizer
Nebulizer (Direct Patient Interface)
2,847 reports
- Stent
Stent, Superficial Femoral Artery, Drug-Eluting
2,846 reports
What this shows Lithotriptor, Biliary Mechanical carries 2,875 MAUDE reports, ranked #419 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 fell to 127 in 2025, down from an average of 263 in the two years before.
Related Entities for Lithotriptor, Biliary Mechanical
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - SPENCER →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Lithotriptor, Biliary Mechanical: 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 (2,875 here).
Similar death-typed counts
Nearest other device types by death-typed report count (12 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.