System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
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 System LIGHT-BOOK · MAUDE
#613 of 1000 · 1,248 reports · 1994–2018
- BOOK 1,248 reports
- RANK #613 of 1000
- DEATH 7 death-typed
- INJ 342 injury-typed
- MALF 867 malfunction
- SPAN 1994–2018
- PEAK 2008: 358
- PHOTO Lamp, Surgical
Nearest event-volume peer: Lamp, Surgical (10 report gap)
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy sits #613 of 1000 among tracked device types with 1,248 MAUDE reports spanning 1994–2018. 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
System carries 69.5% MALFUNCTION-coded reports, 4.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
- INJ 27.4% corpus 30.3% · below corpus mean (-2.9 pp)
- MALF 69.5% corpus 64.8% · above corpus mean (+4.6 pp)
Lead product-problem code Balloon leak(s) is 16% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 86% of manufacturer-tagged reports · Top event location is 89% of location-tagged rows .
System in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Intervertebra…
Intervertebral Fusion Device With Integrated Fixation, Lumbar
1,268 reports
- Tube, Feeding
Tube, Feeding
1,266 reports
- System (this)
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
1,248 reports
- Lamp, Surgical
Lamp, Surgical
1,238 reports
- Clamp
Clamp
1,235 reports
- Tube
Tube, Gastro-Enterostomy
1,228 reports
What this shows System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy carries 1,248 MAUDE reports, ranked #613 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 2 in 2015, down from an average of 15 in the two years before.
Related Entities for System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - MARLBOROUGH →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for System: 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 (1,248 here).
Similar death-typed counts
Nearest other device types by death-typed report count (7 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for System 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 System; 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.