Laparoscope, Gynecologic (And Accessories)
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 §884.1720 (Obstetrics/Gynecology panel).
FDA MAUDE casebook
openFDA event book Laparoscope, Gynecologic MID-BOOK · MAUDE
#162 of 1000 · 16,889 reports · 1993–2026
- BOOK 16,889 reports
- RANK #162 of 1000
- DEATH 24 death-typed
- INJ 639 injury-typed
- MALF 16,135 malfunction
- SPAN 1993–2026
- PEAK 2025: 4,569
- PHOTO Template
Nearest event-volume peer: Template (26 report gap)
Laparoscope, Gynecologic (And Accessories) sits #162 of 1000 among tracked device types with 16,889 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 → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Laparoscope, Gynecologic carries 95.5% MALFUNCTION-coded reports, 30.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 3.8% corpus 30.3% · below corpus mean (-26.5 pp)
- MALF 95.5% corpus 64.8% · above corpus mean (+30.7 pp)
Lead product-problem code Poor Quality Image is 28% of coded problems · Lead manufacturer OLYMPUS WINTER & IBE GMBH accounts for 74% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .
Laparoscope, Gynecologic in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Appendage Closure, Left Atrial
17,177 reports
- Fastener
Fastener, Fixation, Biodegradable, Soft Tissue
17,071 reports
- Catheter
Catheter, Urological
17,035 reports
- Template
Template
16,915 reports
- Laparoscope (this)
Laparoscope, Gynecologic (And Accessories)
16,889 reports
- Dc-Defibrilla…
Dc-Defibrillator, Low-Energy, (Including Paddles)
16,579 reports
What this shows Laparoscope, Gynecologic (And Accessories) carries 16,889 MAUDE reports, ranked #162 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 rose to 4,569 in 2025, up from an average of 2,160 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Laparoscope, Gynecologic (And Accessories)
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Laparoscope, Gynecologic: 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 (16,889 here).
Similar death-typed counts
Nearest other device types by death-typed report count (24 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Laparoscope, Gynecologic 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 Laparoscope, Gynecologic; 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.