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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
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE
SUBSTANTIALLY EQUIVALENT
1
CATHETER RESEARCH, INC.
SUBSTANTIALLY EQUIVALENT
1
CLEARPATH SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
CLINICAL INNOVATIONS, LLC
SUBSTANTIALLY EQUIVALENT
1
CONMED CORPORATION
SUBSTANTIALLY EQUIVALENT
2
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
5
COOPER SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
COOPERSURGICAL, INC
SUBSTANTIALLY EQUIVALENT
1
COOPERSURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
CROSSBAY MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ENDOCONTROL
SUBSTANTIALLY EQUIVALENT
1
FEMASYS INC.
SUBSTANTIALLY EQUIVALENT
4
GYNETECH PTY. LTD.
SUBSTANTIALLY EQUIVALENT
2
KRONNER PROTOTYPES, INC.
SUBSTANTIALLY EQUIVALENT
1
OBG PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
PANPAC MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
4
REJONI, INC.
SUBSTANTIALLY EQUIVALENT
1
STERLING MEDICAL INC
SUBSTANTIALLY EQUIVALENT
1
THE O R COMPANY PTY LTD
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
45
45
2015
53
53
2016
62
62
2017
64
64
2018
23
23
2019
76
76
2020
119
119
2021
188
188
2022
101
101
2023
88
88
2024
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
158
158
Break
146
146
Unintended Movement
84
84
Inflation Problem
79
79
Material Separation
76
76
Material Fragmentation
69
69
Detachment Of Device Component
55
55
Material Rupture
32
32
Deflation Problem
23
23
Material Puncture/Hole
17
17
Insufficient Information
14
14
Failure to Deflate
14
14
Leak/Splash
12
12
Component Missing
12
12
Improper or Incorrect Procedure or Method
11
11
Device Operates Differently Than Expected
11
11
Structural Problem
10
10
Hole In Material
10
10
Therapeutic or Diagnostic Output Failure
8
8
Material Protrusion/Extrusion
8
8
Component Falling
7
7
Device Dislodged or Dislocated
7
7
Gas/Air Leak
6
6
Burst Container or Vessel
6
6
Fluid/Blood Leak
6
6
Loose or Intermittent Connection
6
6
Difficult to Remove
6
6
Device Slipped
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Torn Material
5
5
Unintended Deflation
5
5
Melted
5
5
Fracture
5
5
Human-Device Interface Problem
5
5
Material Perforation
5
5
Defective Component
5
5
Defective Device
5
5
Malposition of Device
5
5
Use of Device Problem
5
5
Disconnection
4
4
Entrapment of Device
4
4
Physical Resistance/Sticking
4
4
Output Problem
4
4
Material Twisted/Bent
3
3
Material Split, Cut or Torn
3
3
Appropriate Term/Code Not Available
3
3
Bent
3
3
Migration or Expulsion of Device
3
3
Mechanical Problem
3
3
Device Or Device Fragments Location Unknown
3
3
Device Markings/Labelling Problem
2
2
Device Damaged by Another Device
2
2
Human Factors Issue
2
2
Difficult to Open or Close
2
2
Device Contamination with Chemical or Other Material
2
2
Difficult to Insert
2
2
Peeled/Delaminated
2
2
Loss of or Failure to Bond
2
2
Material Disintegration
2
2
Scratched Material
2
2
Sharp Edges
2
2
Device Fell
2
2
Separation Problem
1
1
Noise, Audible
1
1
Mechanics Altered
1
1
Operating System Becomes Nonfunctional
1
1
Packaging Problem
1
1
Positioning Problem
1
1
Pressure Problem
1
1
Electrical /Electronic Property Problem
1
1
Air Leak
1
1
Use of Incorrect Control/Treatment Settings
1
1
Difficult or Delayed Positioning
1
1
Disassembly
1
1
Difficult To Position
1
1
Material Too Rigid or Stiff
1
1
Smoking
1
1
Unstable
1
1
Inadequacy of Device Shape and/or Size
1
1
Inadequate Instructions for Healthcare Professional
1
1
Misconnection
1
1
Unsealed Device Packaging
1
1
Device Contaminated During Manufacture or Shipping
1
1
Maintenance Does Not Comply To Manufacturers Recommendations
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Device Packaging Compromised
1
1
Expulsion
1
1
Fail-Safe Problem
1
1
Sparking
1
1
Device, removal of (non-implant)
1
1
Folded
1
1
Contamination /Decontamination Problem
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Fitting Problem
1
1
Unknown (for use when the device problem is not known)
1
1
Residue After Decontamination
1
1
Tear, Rip or Hole in Device Packaging
1
1
Overfill
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
313
313
No Known Impact Or Consequence To Patient
189
189
No Consequences Or Impact To Patient
109
109
Insufficient Information
76
76
Foreign Body In Patient
62
62
Uterine Perforation
23
23
No Information
21
21
No Code Available
21
21
Device Embedded In Tissue or Plaque
12
12
Laceration(s)
8
8
No Patient Involvement
6
6
Injury
5
5
Perforation
4
4
Abdominal Pain
4
4
Fever
3
3
Hemorrhage/Bleeding
3
3
Bowel Perforation
3
3
Obstruction/Occlusion
2
2
Needle Stick/Puncture
2
2
Rupture
2
2
Pain
2
2
Death
2
2
Abscess
2
2
Adhesion(s)
1
1
Air Embolism
1
1
Bacterial Infection
1
1
Embolus
1
1
Foreign Body Reaction
1
1
Pelvic Inflammatory Disease
1
1
Rash
1
1
Tissue Damage
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoxia
1
1
Internal Organ Perforation
1
1
Nonresorbable materials, unretrieved in body
1
1
Discomfort
1
1
Joint Swelling
1
1
Foreign body, removal of
1
1
Abnormal Vaginal Discharge
1
1
Low Oxygen Saturation
1
1
Skin Tears
1
1
Test Result
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Unspecified Gastrointestinal Problem
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Clinical Innovations, LLC
II
May-26-2020
2
Cooper Surgical, Inc.
II
Nov-26-2012
3
CooperSurgical, Inc.
II
Dec-06-2023
4
CooperSurgical, Inc.
II
Jun-08-2015
5
CooperSurgical, Inc.
II
Sep-05-2014
6
CooperSurgical, Inc.
II
Jun-11-2014
7
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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