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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 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 46 46
Suction Failure 38 38
Break 36 36
Suction Problem 33 33
Detachment of Device or Device Component 29 29
Packaging Problem 27 27
Contamination /Decontamination Problem 25 25
Leak/Splash 18 18
Crack 14 14
Obstruction of Flow 14 14
Fluid/Blood Leak 13 13
Material Fragmentation 13 13
Contamination 12 12
Device Contaminated During Manufacture or Shipping 12 12
Mechanical Problem 11 11
Device Contamination with Chemical or Other Material 10 10
Material Puncture/Hole 10 10
Decrease in Suction 8 8
Complete Blockage 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Failure to Eject 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Corroded 6 6
Fracture 4 4
Insufficient Information 4 4
Sharp Edges 3 3
Temperature Problem 3 3
Collapse 3 3
Material Separation 3 3
No Flow 3 3
Shipping Damage or Problem 2 2
Smoking 2 2
Use of Device Problem 2 2
Failure to Conduct 2 2
Burst Container or Vessel 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 2 2
Material Deformation 2 2
Component Missing 2 2
Sparking 2 2
Battery Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Structural Problem 1 1
Defective Device 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
Deflation Problem 1 1
Degraded 1 1
Material Discolored 1 1
Entrapment of Device 1 1
Clumping in Device or Device Ingredient 1 1
Coagulation in Device or Device Ingredient 1 1
Thermal Decomposition of Device 1 1
Vibration 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Problem with Sterilization 1 1
Unexpected Therapeutic Results 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 219 219
Insufficient Information 60 60
No Known Impact Or Consequence To Patient 59 59
No Consequences Or Impact To Patient 15 15
No Patient Involvement 13 13
Foreign Body In Patient 11 11
Hemorrhage/Bleeding 6 6
Laceration(s) 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Pneumothorax 4 4
Pulmonary Edema 2 2
Hemothorax 2 2
Exposure to Body Fluids 2 2
Cardiac Arrest 2 2
Death 2 2
No Code Available 2 2
Device Embedded In Tissue or Plaque 2 2
Blood Loss 2 2
No Information 1 1
Unspecified Heart Problem 1 1
Pleural Empyema 1 1
Deposits 1 1
Low Blood Pressure/ Hypotension 1 1
Airway Obstruction 1 1
Anemia 1 1
Bacterial Infection 1 1
Liver Laceration(s) 1 1
Ulcer 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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