• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device apparatus, suction, operating-room, wall vacuum powered
Product CodeGCX
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2017 45 45
2018 49 49
2019 65 65
2020 65 65
2021 65 65
2022 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Problem 41 41
Break 38 38
Delivered as Unsterile Product 30 30
Contamination /Decontamination Problem 25 25
Detachment of Device or Device Component 23 23
Suction Failure 23 23
Leak/Splash 19 19
Fluid Leak 18 18
Packaging Problem 16 16
Device Contamination with Chemical or Other Material 14 14
Crack 12 12
Contamination 11 11
Device Contaminated During Manufacture or Shipping 9 9
Decrease in Suction 8 8
Detachment Of Device Component 8 8
Material Fragmentation 8 8
Mechanical Problem 7 7
Obstruction of Flow 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Corroded 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Device Inoperable 5 5
Tear, Rip or Hole in Device Packaging 4 4
Device Operates Differently Than Expected 4 4
Burst Container or Vessel 4 4
Appropriate Term/Code Not Available 4 4
Sharp Edges 3 3
No Flow 3 3
Collapse 3 3
Fracture 3 3
Smoking 3 3
Use of Device Problem 2 2
Vibration 2 2
Improper or Incorrect Procedure or Method 2 2
Kinked 2 2
Fitting Problem 2 2
Defective Component 2 2
Component Missing 2 2
Device Packaging Compromised 2 2
Material Deformation 2 2
Defective Device 2 2
Aspiration Issue 2 2
Complete Blockage 2 2
Thermal Decomposition of Device 2 2
Material Puncture/Hole 2 2
Material Separation 2 2
Shipping Damage or Problem 2 2
Insufficient Information 2 2
Therapeutic or Diagnostic Output Failure 2 2
Misassembly by Users 1 1
Output Problem 1 1
Scratched Material 1 1
Temperature Problem 1 1
Component Misassembled 1 1
Activation Problem 1 1
Unintended Deflation 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Difficult to Remove 1 1
Melted 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Energy Output Problem 1 1
Overheating of Device 1 1
Pacing Problem 1 1
Particulates 1 1
Loss of Power 1 1
Clumping in Device or Device Ingredient 1 1
Air Leak 1 1
Component Falling 1 1
Deflation Problem 1 1
Material Discolored 1 1
Blocked Connection 1 1
Device Or Device Fragments Location Unknown 1 1
Sparking 1 1
Device Markings/Labelling Problem 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Difficult to Advance 1 1
Difficult to Open or Close 1 1
Structural Problem 1 1
Problem with Sterilization 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 111 111
No Known Impact Or Consequence To Patient 97 97
Insufficient Information 46 46
No Consequences Or Impact To Patient 25 25
No Patient Involvement 24 24
No Information 13 13
Foreign Body In Patient 10 10
Death 8 8
Hemorrhage/Bleeding 8 8
Pneumothorax 5 5
Laceration(s) 4 4
Pain 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Vomiting 3 3
Aspiration/Inhalation 3 3
Exposure to Body Fluids 2 2
Cardiac Arrest 2 2
Cardiopulmonary Arrest 2 2
Pulmonary Edema 2 2
Hemothorax 2 2
Unspecified Infection 2 2
Blood Loss 2 2
No Code Available 2 2
Pleural Empyema 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Ulcer 1 1
Discomfort 1 1
Injury 1 1
Burn, Thermal 1 1
Inflammation 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress 1 1
Liver Laceration(s) 1 1
Deposits 1 1
Hearing Loss 1 1
Bacterial Infection 1 1
Airway Obstruction 1 1
Anemia 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
-
-