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TPLC
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Device
cannula, manipulator/injector, uterine
Regulation Description
Obstetric-gynecologic specialized manual instrument.
Product Code
LKF
Regulation Number
884.4530
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOPERSURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
FEMASYS INC.
SUBSTANTIALLY EQUIVALENT
2
LI MEDICAL CORPORATION LTD.
SUBSTANTIALLY EQUIVALENT
1
REJONI, INC.
SUBSTANTIALLY EQUIVALENT
1
THE O R COMPANY PTY LTD
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
119
119
2021
188
188
2022
101
101
2023
88
88
2024
125
125
2025
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
152
152
Unintended Movement
83
83
Break
67
67
Material Separation
67
67
Material Fragmentation
61
61
Inflation Problem
40
40
Material Rupture
29
29
Failure to Deflate
27
27
Deflation Problem
18
18
Material Puncture/Hole
11
11
Insufficient Information
10
10
Structural Problem
9
9
Leak/Splash
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Therapeutic or Diagnostic Output Failure
5
5
Unintended Deflation
5
5
Fluid/Blood Leak
5
5
Material Protrusion/Extrusion
4
4
Disconnection
4
4
Physical Resistance/Sticking
4
4
Fracture
4
4
Improper or Incorrect Procedure or Method
4
4
Output Problem
3
3
Material Twisted/Bent
3
3
Entrapment of Device
3
3
Peeled/Delaminated
3
3
Mechanical Problem
3
3
Gas/Air Leak
3
3
Melted
3
3
Defective Component
3
3
Material Split, Cut or Torn
3
3
Human-Device Interface Problem
2
2
Sharp Edges
2
2
Device Contaminated During Manufacture or Shipping
2
2
Loss of or Failure to Bond
2
2
Burst Container or Vessel
2
2
Device Markings/Labelling Problem
2
2
Device Fell
2
2
Defective Device
2
2
Device Dislodged or Dislocated
2
2
Difficult to Open or Close
2
2
Component Missing
2
2
Device Damaged by Another Device
1
1
Malposition of Device
1
1
Fitting Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Migration or Expulsion of Device
1
1
Loose or Intermittent Connection
1
1
Tear, Rip or Hole in Device Packaging
1
1
Material Perforation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
390
390
Insufficient Information
78
78
No Consequences Or Impact To Patient
52
52
Foreign Body In Patient
39
39
No Known Impact Or Consequence To Patient
34
34
Uterine Perforation
13
13
Laceration(s)
8
8
Hemorrhage/Bleeding
5
5
No Information
3
3
Perforation
2
2
Abnormal Vaginal Discharge
2
2
Perforation of Vessels
2
2
Rupture
2
2
Needle Stick/Puncture
2
2
Pain
1
1
Pelvic Inflammatory Disease
1
1
Abdominal Pain
1
1
Bacterial Infection
1
1
Unspecified Infection
1
1
Unspecified Tissue Injury
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Device Embedded In Tissue or Plaque
1
1
No Code Available
1
1
Unspecified Gastrointestinal Problem
1
1
Skin Tears
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Clinical Innovations, LLC
II
May-26-2020
2
CooperSurgical, Inc.
II
Dec-06-2023
3
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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