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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
2018 49 49
2019 65 65
2020 65 65
2021 65 65
2022 72 72
2023 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 37 37
Suction Problem 37 37
Break 36 36
Contamination /Decontamination Problem 25 25
Suction Failure 25 25
Detachment of Device or Device Component 23 23
Leak/Splash 17 17
Packaging Problem 15 15
Obstruction of Flow 14 14
Fluid/Blood Leak 14 14
Crack 12 12
Contamination 11 11
Device Contamination with Chemical or Other Material 11 11
Device Contaminated During Manufacture or Shipping 10 10
Decrease in Suction 9 9
Material Fragmentation 8 8
Mechanical Problem 7 7
Corroded 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Appropriate Term/Code Not Available 4 4
Tear, Rip or Hole in Device Packaging 4 4
Fracture 4 4
Collapse 3 3
Detachment Of Device Component 3 3
Device Inoperable 3 3
No Flow 3 3
Sharp Edges 3 3
Insufficient Information 2 2
Temperature Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 2 2
Material Deformation 2 2
Fitting Problem 2 2
Defective Component 2 2
Component Missing 2 2
Use of Device Problem 2 2
Vibration 2 2
Material Separation 2 2
Shipping Damage or Problem 2 2
Material Puncture/Hole 2 2
Thermal Decomposition of Device 2 2
Burst Container or Vessel 2 2
Complete Blockage 2 2
Clumping in Device or Device Ingredient 1 1
Coagulation in Device or Device Ingredient 1 1
Loose or Intermittent Connection 1 1
Deflation Problem 1 1
Material Discolored 1 1
Entrapment of Device 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Melted 1 1
Energy Output Problem 1 1
Pacing Problem 1 1
Particulates 1 1
Loss of Power 1 1
Smoking 1 1
Problem with Sterilization 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Improper or Incorrect Procedure or Method 1 1
Structural Problem 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Sparking 1 1
Aspiration Issue 1 1
Battery Problem 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Improper Flow or Infusion 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Scratched Material 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Component Misassembled 1 1
Device Fell 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 138 138
No Known Impact Or Consequence To Patient 76 76
Insufficient Information 54 54
No Consequences Or Impact To Patient 22 22
No Patient Involvement 20 20
Foreign Body In Patient 9 9
Hemorrhage/Bleeding 8 8
No Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Death 5 5
Laceration(s) 4 4
Pneumothorax 4 4
Pulmonary Edema 2 2
Unspecified Infection 2 2
Pain 2 2
Hemothorax 2 2
Exposure to Body Fluids 2 2
Cardiac Arrest 2 2
Aspiration/Inhalation 2 2
No Code Available 2 2
Device Embedded In Tissue or Plaque 2 2
Vomiting 2 2
Blood Loss 2 2
Ulcer 1 1
Discomfort 1 1
Burn, Thermal 1 1
Pleural Empyema 1 1
Bacterial Infection 1 1
Airway Obstruction 1 1
Anemia 1 1
Deposits 1 1
Low Blood Pressure/ Hypotension 1 1
Liver Laceration(s) 1 1
Respiratory Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Apr-30-2018
2 Stryker Corporation II Mar-02-2018
3 Synaptive Medical Inc II Jun-25-2021
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