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TPLC
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Device
cannula, manipulator/injector, uterine
Product Code
LKF
Regulation Number
884.4530
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
COOPERSURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
REJONI, INC.
SUBSTANTIALLY EQUIVALENT
1
THE O R COMPANY PTY LTD
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
76
76
2020
119
119
2021
188
188
2022
101
101
2023
88
88
2024
27
27
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
140
140
Unintended Movement
83
83
Break
78
78
Material Separation
63
63
Inflation Problem
56
56
Material Fragmentation
53
53
Material Rupture
30
30
Deflation Problem
21
21
Material Puncture/Hole
15
15
Failure to Deflate
13
13
Structural Problem
10
10
Leak/Splash
10
10
Therapeutic or Diagnostic Output Failure
8
8
Gas/Air Leak
6
6
Insufficient Information
6
6
Unintended Deflation
5
5
Material Protrusion/Extrusion
5
5
Fluid/Blood Leak
5
5
Component Missing
5
5
Defective Device
4
4
Fracture
4
4
Disconnection
4
4
Defective Component
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Human-Device Interface Problem
4
4
Physical Resistance/Sticking
4
4
Material Split, Cut or Torn
3
3
Output Problem
3
3
Material Twisted/Bent
3
3
Burst Container or Vessel
3
3
Entrapment of Device
3
3
Loose or Intermittent Connection
3
3
Mechanical Problem
3
3
Melted
3
3
Malposition of Device
3
3
Improper or Incorrect Procedure or Method
3
3
Use of Device Problem
2
2
Peeled/Delaminated
2
2
Loss of or Failure to Bond
2
2
Device Markings/Labelling Problem
2
2
Difficult to Open or Close
2
2
Device Dislodged or Dislocated
2
2
Sharp Edges
2
2
Device Fell
2
2
Separation Problem
1
1
Appropriate Term/Code Not Available
1
1
Fail-Safe Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Device Damaged by Another Device
1
1
Mechanics Altered
1
1
Pressure Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Electrical /Electronic Property Problem
1
1
Difficult to Insert
1
1
Inadequate Instructions for Healthcare Professional
1
1
Migration or Expulsion of Device
1
1
Difficult to Remove
1
1
Material Too Rigid or Stiff
1
1
Device Slipped
1
1
Smoking
1
1
Unstable
1
1
Fitting Problem
1
1
Material Perforation
1
1
Residue After Decontamination
1
1
Tear, Rip or Hole in Device Packaging
1
1
Contamination /Decontamination Problem
1
1
Activation, Positioning or Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
307
307
No Known Impact Or Consequence To Patient
83
83
Insufficient Information
74
74
No Consequences Or Impact To Patient
71
71
Foreign Body In Patient
30
30
Uterine Perforation
15
15
Laceration(s)
6
6
No Information
5
5
Hemorrhage/Bleeding
3
3
Perforation
2
2
Rupture
2
2
Needle Stick/Puncture
2
2
Skin Tears
1
1
Bowel Perforation
1
1
Injury
1
1
No Code Available
1
1
Unspecified Gastrointestinal Problem
1
1
Unspecified Tissue Injury
1
1
Abnormal Vaginal Discharge
1
1
Pain
1
1
Pelvic Inflammatory Disease
1
1
Abdominal Pain
1
1
Bacterial Infection
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Device Embedded In Tissue or Plaque
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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