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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, suction, operating-room, wall vacuum powered
Product CodeGCX
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2019 65 65
2020 65 65
2021 65 65
2022 72 72
2023 59 59
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 46 46
Suction Failure 38 38
Break 34 34
Suction Problem 33 33
Contamination /Decontamination Problem 25 25
Detachment of Device or Device Component 23 23
Packaging Problem 19 19
Leak/Splash 18 18
Crack 14 14
Obstruction of Flow 14 14
Material Fragmentation 13 13
Fluid/Blood Leak 12 12
Contamination 12 12
Device Contaminated During Manufacture or Shipping 12 12
Device Contamination with Chemical or Other Material 10 10
Mechanical Problem 9 9
Decrease in Suction 8 8
Complete Blockage 7 7
Corroded 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 4 4
Material Puncture/Hole 4 4
Collapse 3 3
Fracture 3 3
Sharp Edges 3 3
Temperature Problem 3 3
No Flow 3 3
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 2 2
Material Deformation 2 2
Component Missing 2 2
Burst Container or Vessel 2 2
Failure to Conduct 2 2
Use of Device Problem 2 2
Material Separation 2 2
Shipping Damage or Problem 2 2
Smoking 2 2
Problem with Sterilization 1 1
Unexpected Therapeutic Results 1 1
Vibration 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Loose or Intermittent Connection 1 1
Energy Output Problem 1 1
Pacing Problem 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Off-Label Use 1 1
Clumping in Device or Device Ingredient 1 1
Coagulation in Device or Device Ingredient 1 1
Thermal Decomposition of Device 1 1
Deflation Problem 1 1
Degraded 1 1
Material Discolored 1 1
Entrapment of Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Structural Problem 1 1
Defective Device 1 1
Sparking 1 1
Battery Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Improper Flow or Infusion 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Scratched Material 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Device Fell 1 1
Component Misassembled 1 1
Activation Problem 1 1
Unintended Deflation 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 189 189
No Known Impact Or Consequence To Patient 59 59
Insufficient Information 57 57
No Consequences Or Impact To Patient 15 15
No Patient Involvement 13 13
Foreign Body In Patient 10 10
Hemorrhage/Bleeding 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Laceration(s) 5 5
Pneumothorax 4 4
Blood Loss 2 2
Device Embedded In Tissue or Plaque 2 2
Cardiac Arrest 2 2
Pulmonary Edema 2 2
Hemothorax 2 2
Exposure to Body Fluids 2 2
Death 2 2
No Code Available 2 2
Liver Laceration(s) 1 1
Pleural Empyema 1 1
Ulcer 1 1
Airway Obstruction 1 1
Anemia 1 1
Bacterial Infection 1 1
No Information 1 1
Low Blood Pressure/ Hypotension 1 1
Deposits 1 1
Discomfort 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Jan-18-2024
2 Synaptive Medical Inc II Jun-25-2021
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