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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, manipulator/injector, uterine
Product CodeLKF
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
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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