Insufflator, Hysteroscopic
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 §884.1700 (Obstetrics/Gynecology panel).
FDA MAUDE casebook
openFDA event book Insufflator, Hysteroscopic LIGHT-BOOK · MAUDE
#864 of 1000 · 541 reports · 1992–2026
- BOOK 541 reports
- RANK #864 of 1000
- DEATH 12 death-typed
- INJ 88 injury-typed
- MALF 434 malfunction
- SPAN 1992–2026
- PEAK 2021: 130
- PHOTO Insufflator
Nearest event-volume peer: Insufflator, Automatic Carbon-Dioxide For Endoscope (1 report gap)
Insufflator, Hysteroscopic sits #864 of 1000 among tracked device types with 541 MAUDE reports spanning 1992–2026. 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
Insufflator, Hysteroscopic carries 80.2% MALFUNCTION-coded reports, 15.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
- INJ 16.3% corpus 30.3% · below corpus mean (-14.0 pp)
- MALF 80.2% corpus 64.8% · above corpus mean (+15.4 pp)
Lead product-problem code Material Fragmentation is 32% of coded problems · Lead manufacturer HOLOGIC, INC. accounts for 61% of manufacturer-tagged reports · Top event location is 38% of location-tagged rows .
Insufflator, Hysteroscopic in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Collector
Collector, Ostomy
543 reports
- Insufflator (this)
Insufflator, Hysteroscopic
541 reports
- Insufflator
Insufflator, Automatic Carbon-Dioxide For Endoscope
540 reports
- Bag
Bag, Urinary, Ileostomy
539 reports
- Container
Container, Specimen, Sterile
539 reports
- Accessories
Accessories, Pump, Infusion
537 reports
What this shows Insufflator, Hysteroscopic carries 541 MAUDE reports, ranked #864 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 (46) held close to the prior two-year average of 39.
Related Entities for Insufflator, Hysteroscopic
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Insufflator, Hysteroscopic: 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 (541 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 Insufflator, Hysteroscopic 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 Insufflator, Hysteroscopic; 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.