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2026 data FDA MAUDE openFDA FDA Class I

Laparoscopic Accessories, Gynecologic

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §884.1720 (Obstetrics/Gynecology panel).

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FDA MAUDE casebook

openFDA event book Laparoscopic Accessories, Gynecologic LIGHT-BOOK · MAUDE

#884 of 1000 · 508 reports · 2009–2026

  • BOOK 508 reports
  • RANK #884 of 1000
  • DEATH 0 death-typed
  • INJ 87 injury-typed
  • MALF 420 malfunction
  • SPAN 2009–2026
  • PEAK 2021: 123
  • PHOTO Infusor

Nearest event-volume peer: Infusor, Pressure, For I.V. Bags (0 report gap)

Laparoscopic Accessories, Gynecologic sits #884 of 1000 among tracked device types with 508 MAUDE reports spanning 2009–2026. 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

Laparoscopic Accessories, Gynecologic carries 82.7% MALFUNCTION-coded reports, 17.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 17.1% corpus 30.3% · below corpus mean (-13.2 pp)
  • MALF 82.7% corpus 64.8% · above corpus mean (+17.8 pp)

Lead product-problem code Break is 39% of coded problems · Lead manufacturer APPLIED MEDICAL RESOURCES accounts for 97% of manufacturer-tagged reports · Top event location I is 53% of location-tagged rows .

Laparoscopic Accessories, Gynecologic in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Laparoscopic Accessories, Gynecologic carries 508 MAUDE reports, ranked #884 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 420 (82.7%)
Injury 87 (17.1%)
1 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

377 (71.1%)
Required Intervention 63 (11.9%)
Other 59 (11.1%)
R 19 (3.6%)
Hospitalization 5 (0.9%)
O 2 (0.4%)
H 1 (0.2%)
L 1 (0.2%)
S 1 (0.2%)
Disability 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Break 217
Material Separation 63
Detachment of Device or Device Component 50
Mechanical Problem 39
Detachment Of Device Component 27
Material Fragmentation 26
Material Integrity Problem 23
Material Frayed 16
Mechanical Jam 15
Other (for use when an appropriate device code cannot be identified) 13
Difficult to Open or Close 10
Solder Joint Fracture 10
Adverse Event Without Identified Device or Use Problem 8
Device Operates Differently Than Expected 7
Fracture 7
Patient Device Interaction Problem 6
Physical Resistance/Sticking 6
Sharp Edges 5
Defective Device 3
Entrapment of Device 3

Yearly Trend

09
2009: 13
12
2012: 2
14
2014: 7
15
2015: 23
16
2016: 26
17
2017: 31
18
2018: 23
19
2019: 56
20
2020: 105
21
2021: 123
22
2022: 20
23
2023: 25
24
2024: 31
25
2025: 11
26
2026: 12

Reports fell to 11 in 2025, down from an average of 28 in the two years before.

Related Entities for Laparoscopic Accessories, Gynecologic

Top Manufacturers

APPLIED MEDICAL RESOURCES 131
AESCULAP AG 4

Event Locations

I 268 (52.8%)
179 (35.2%)
HOSPITAL 55 (10.8%)
NO INFORMATION 6 (1.2%)

Compare APPLIED MEDICAL RESOURCES vs AESCULAP AG →

Nationwide devices with a comparable report-volume footprint

Laparoscopic Accessories, Gynecologic carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (508 here).

Infusor, Pressure, For I.V. Bags 508 Cutter, Wire 510 Stylet, Tracheal Tube 506 Tubing, Pressure And Accessories 510

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Laparoscopic Accessories, 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 Laparoscopic Accessories, 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.