2026 data FDA MAUDE openFDA FDA Class II

Cannula, Manipulator/Injector, Uterine

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 §884.4530 (Obstetrics/Gynecology panel).

FDA MAUDE casebook

openFDA event book Cannula, Manipulator/Injector, Uterine LIGHT-BOOK · MAUDE

#528 of 1000 · 1,772 reports · 1992–2026

  • BOOK 1,772 reports
  • RANK #528 of 1000
  • DEATH 2 death-typed
  • INJ 248 injury-typed
  • MALF 1,456 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 189
  • PHOTO Cannula, Nasal, Oxygen

Nearest event-volume peer: Cannula, Nasal, Oxygen (5 report gap)

Cannula, Manipulator/Injector, Uterine sits #528 of 1000 among tracked device types with 1,772 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

Cannula, Manipulator/Injector, Uterine carries 82.2% MALFUNCTION-coded reports, 17.3pp 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 14.0% corpus 30.3% · below corpus mean (-16.3 pp)
  • MALF 82.2% corpus 64.8% · above corpus mean (+17.3 pp)

Lead product-problem code Break is 17% of coded problems · Lead manufacturer ETHICON ENDO-SURGERY, LLC. accounts for 48% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Cannula, Manipulator/Injector, Uterine in the event-volume neighbourhood

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

reports

What this shows Cannula, Manipulator/Injector, Uterine carries 1,772 MAUDE reports, ranked #528 of 1000.

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

Event Types

Malfunction 1,456 (82.2%)
Injury 248 (14.0%)
35 (2.0%)
Other 31 (1.7%)
Death 2 (0.1%)

Patient Outcomes

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

1,303 (71.7%)
Other 281 (15.5%)
Required Intervention 148 (8.1%)
R 38 (2.1%)
Hospitalization 20 (1.1%)
O 8 (0.4%)
Disability 5 (0.3%)
S 4 (0.2%)
C 3 (0.2%)
L 3 (0.2%)
Death 2 (0.1%)
Congenital Anomaly 1 (0.1%)
Invalid Data 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Break 280
Detachment of Device or Device Component 213
Detachment Of Device Component 168
Inflation Problem 120
Material Separation 116
Replace 111
Material Fragmentation 107
Burst Container or Vessel 92
Unintended Movement 91
Balloon rupture 45
Tip breakage 45
Material Rupture 42
Balloon burst 35
Deflation Problem 33
Component Falling 31
Failure to Deflate 30
Improper or Incorrect Procedure or Method 30
Difficult to Remove 28
Component(s), broken 26
Insufficient Device Problem Information 24

Yearly Trend

92
1992: 2
93
1993: 3
94
1994: 2
95
1995: 1
96
1996: 8
97
1997: 3
98
1998: 9
99
1999: 7
00
2000: 8
01
2001: 33
02
2002: 5
03
2003: 17
04
2004: 9
05
2005: 34
06
2006: 85
07
2007: 36
08
2008: 59
09
2009: 52
10
2010: 46
11
2011: 98
12
2012: 104
13
2013: 53
14
2014: 45
15
2015: 53
16
2016: 62
17
2017: 64
18
2018: 23
19
2019: 76
20
2020: 119
21
2021: 189
22
2022: 100
23
2023: 88
24
2024: 125
25
2025: 96
26
2026: 58

Reports in 2025 (96) held close to the prior two-year average of 107.

Related Entities for Cannula, Manipulator/Injector, Uterine

Event Locations

907 (51.2%)
HOSPITAL 298 (16.8%)
I 263 (14.8%)
NOT APPLICABLE 139 (7.8%)
NO INFORMATION 117 (6.6%)
OTHER 39 (2.2%)
AMBULATORY SURGICAL FACILITY 6 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)
INVALID DATA 1 (0.1%)

Compare ETHICON ENDO-SURGERY, LLC. vs COOK INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Cannula, Manipulator/Injector, Uterine: 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 (1,772 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Cannula, Manipulator/Injector, Uterine 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 Cannula, Manipulator/Injector, Uterine; 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.