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2026 data FDA MAUDE openFDA FDA Class III

Laparoscopic Contraceptive Tubal Occlusion Device

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 III (highest risk, premarket approval required), regulated under 21 CFR §884.5380 (Obstetrics/Gynecology panel).

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FDA MAUDE casebook

openFDA event book Laparoscopic Contraceptive Tubal Occlusion… LIGHT-BOOK · MAUDE

#695 of 1000 · 893 reports · 1994–2026

  • BOOK 893 reports
  • RANK #695 of 1000
  • DEATH 1 death-typed
  • INJ 595 injury-typed
  • MALF 264 malfunction
  • SPAN 1994–2026
  • PEAK 2018: 114
  • PHOTO Unit

Nearest event-volume peer: Unit, Cautery, Thermal, Ac-Powered (0 report gap)

Laparoscopic Contraceptive Tubal Occlusion Device sits #695 of 1000 among tracked device types with 893 MAUDE reports spanning 1994–2026. 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 →

Injury-coded reports run above the device-type norm

Laparoscopic Contraceptive Tubal Occlusion… carries 66.6% INJURY-coded reports, 36.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 66.6% corpus 30.3% · above corpus mean (+36.3 pp)
  • MALF 29.6% corpus 64.8% · below corpus mean (-35.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 17% of coded problems · Lead manufacturer UNK accounts for 43% of manufacturer-tagged reports · Top event location is 32% of location-tagged rows .

Laparoscopic Contraceptive Tubal Occlusion… in the event-volume neighbourhood

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

reports

What this shows Laparoscopic Contraceptive Tubal Occlusion Device carries 893 MAUDE reports, ranked #695 of 1000.

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

Event Types

Injury 595 (66.6%)
Malfunction 264 (29.6%)
Other 21 (2.4%)
12 (1.3%)
Death 1 (0.1%)

Patient Outcomes

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

291 (24.2%)
Other 221 (18.4%)
Required Intervention 150 (12.5%)
Hospitalization 143 (11.9%)
R 112 (9.3%)
S 99 (8.2%)
Disability 74 (6.2%)
O 64 (5.3%)
L 20 (1.7%)
H 13 (1.1%)
Life Threatening 13 (1.1%)
Death 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 132
Migration or Expulsion of Device 91
Insufficient Device Problem Information 80
Patient-Device Incompatibility 75
Break 47
Failure To Adhere Or Bond 43
Device Operates Differently Than Expected 41
Migration 41
Detachment Of Device Component 26
Device Dislodged or Dislocated 26
Positioning Failure 24
Misfire 23
Appropriate Device Problem Term/Code Not Available 22
Difficult to Remove 20
Replace 20
Unsealed Device Packaging 20
Sticking 17
Entrapment of Device 15
Malfunction 15
Detachment of Device or Device Component 14

Yearly Trend

94
1994: 2
95
1995: 1
96
1996: 31
97
1997: 17
98
1998: 20
99
1999: 15
00
2000: 8
01
2001: 9
02
2002: 11
03
2003: 5
05
2005: 7
06
2006: 3
07
2007: 17
08
2008: 6
09
2009: 21
10
2010: 24
11
2011: 50
12
2012: 49
13
2013: 25
14
2014: 49
15
2015: 62
16
2016: 63
17
2017: 105
18
2018: 114
19
2019: 60
20
2020: 48
21
2021: 24
22
2022: 20
23
2023: 6
24
2024: 9
25
2025: 7
26
2026: 5

Reports in 2025 (7) held close to the prior two-year average of 8.

Related Entities for Laparoscopic Contraceptive Tubal Occlusion Device

Top Manufacturers

UNK 95
BAYER HEALTHCARE LLC 67
GYRUS ACMI, INC 32
GYRUS ACMI, INC. 29

Event Locations

289 (32.4%)
NO INFORMATION 254 (28.4%)
HOSPITAL 179 (20.0%)
I 140 (15.7%)
AMBULATORY SURGICAL FACILITY 11 (1.2%)
INVALID DATA 7 (0.8%)
UNKNOWN 7 (0.8%)
OTHER 2 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.2%)
HOME 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare UNK vs BAYER HEALTHCARE LLC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Laparoscopic Contraceptive Tubal Occlusion…: 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 (893 here).

Unit, Cautery, Thermal, Ac-Powered 893 Flow Cytometric Reagents And Accessories. 896 Intrasaccular Flow Disruption Device 889 Probe, Radiofrequency Lesion 897

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Laparoscopic Contraceptive Tubal Occlusion… 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 Contraceptive Tubal Occlusion…; 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.