Insufflator, Laparoscopic
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 §884.1730 (Obstetrics/Gynecology panel).
FDA MAUDE casebook
openFDA event book Insufflator, Laparoscopic LIGHT-BOOK · MAUDE
#258 of 1000 · 7,499 reports · 1992–2026
- BOOK 7,499 reports
- RANK #258 of 1000
- DEATH 34 death-typed
- INJ 816 injury-typed
- MALF 6,605 malfunction
- SPAN 1992–2026
- PEAK 2025: 1,519
- PHOTO Knife, Ophthalmic
Nearest event-volume peer: Knife, Ophthalmic (3 report gap)
Insufflator, Laparoscopic sits #258 of 1000 among tracked device types with 7,499 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, Laparoscopic carries 88.1% MALFUNCTION-coded reports, 23.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.5% corpus 1.5% · below corpus mean (-1.1 pp)
- INJ 10.9% corpus 30.3% · below corpus mean (-19.4 pp)
- MALF 88.1% corpus 64.8% · above corpus mean (+23.3 pp)
Lead product-problem code Pressure Problem is 14% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 75% of manufacturer-tagged reports · Top event location is 82% of location-tagged rows .
Insufflator, Laparoscopic in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Nasopharyngos…
Nasopharyngoscope (Flexible Or Rigid)
7,691 reports
- System
System, X-Ray, Angiographic
7,625 reports
- Glucose Oxida…
Glucose Oxidase, Glucose
7,604 reports
- Knife
Knife, Ophthalmic
7,502 reports
- Insufflator (this)
Insufflator, Laparoscopic
7,499 reports
- Laryngoscope
Laryngoscope, Rigid
7,361 reports
What this shows Insufflator, Laparoscopic carries 7,499 MAUDE reports, ranked #258 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 (1,519) held close to the prior two-year average of 1,187.
Related Entities for Insufflator, Laparoscopic
Top Manufacturers
Event Locations
Compare SHIRAKAWA OLYMPUS CO., LTD. vs OLYMPUS MEDICAL SYSTEMS CORP. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Insufflator, Laparoscopic: 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 (7,499 here).
Similar death-typed counts
Nearest other device types by death-typed report count (34 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Insufflator, Laparoscopic 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, Laparoscopic; 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.