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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device cannula, manipulator/injector, uterine
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeLKF
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
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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