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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
2014 32 32
2015 52 52
2016 99 99
2017 45 45
2018 49 49
2019 65 65
2020 65 65
2021 65 65
2022 72 72
2023 59 59
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 106 106
Suction Problem 73 73
Break 51 51
Delivered as Unsterile Product 50 50
Suction Failure 38 38
Fluid/Blood Leak 30 30
Leak/Splash 29 29
Packaging Problem 28 28
Detachment of Device or Device Component 28 28
Crack 26 26
Contamination /Decontamination Problem 25 25
Material Fragmentation 19 19
Obstruction of Flow 15 15
Device Packaging Compromised 15 15
Device Contaminated During Manufacture or Shipping 13 13
Detachment Of Device Component 13 13
Contamination 12 12
Out-Of-Box Failure 12 12
Decrease in Suction 11 11
Burst Container or Vessel 9 9
Mechanical Problem 9 9
Corroded 8 8
Complete Blockage 8 8
Device Inoperable 8 8
Device Operates Differently Than Expected 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Residue After Decontamination 7 7
Failure to Eject 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Smoking 6 6
Material Separation 5 5
Material Puncture/Hole 5 5
Collapse 5 5
Fracture 4 4
Tear, Rip or Hole in Device Packaging 4 4
Material Integrity Problem 4 4
Insufficient Information 4 4
Appropriate Term/Code Not Available 4 4
Temperature Problem 3 3
Component Missing 3 3
Sharp Edges 3 3
No Flow 3 3
Material Discolored 3 3
Thermal Decomposition of Device 3 3
Overheating of Device 3 3
Kinked 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Component 2 2
Fitting Problem 2 2
Material Rupture 2 2
Use of Device Problem 2 2
Vibration 2 2
Structural Problem 2 2
Defective Device 2 2
Device Or Device Fragments Location Unknown 2 2
Aspiration Issue 2 2
Shipping Damage or Problem 2 2
Partial Blockage 2 2
Failure to Conduct 2 2
Unintended Ejection 2 2
Hole In Material 2 2
Loose or Intermittent Connection 2 2
Material Deformation 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 2 2
Material Twisted/Bent 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Component Misassembled 1 1
Scratched Material 1 1
Activation Problem 1 1
Unintended Deflation 1 1
Wrong Label 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Difficult to Advance 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Markings/Labelling Problem 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Fell 1 1
Labelling, Instructions for Use or Training Problem 1 1
Melted 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Disconnection 1 1
Entrapment of Device 1 1
Component Falling 1 1
Deflation Problem 1 1
Degraded 1 1
Air Leak 1 1
Bent 1 1
Clumping in Device or Device Ingredient 1 1
Coagulation in Device or Device Ingredient 1 1
Device Reprocessing Problem 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Problem with Sterilization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 203 203
No Clinical Signs, Symptoms or Conditions 202 202
No Patient Involvement 61 61
Insufficient Information 59 59
No Consequences Or Impact To Patient 43 43
No Information 22 22
Foreign Body In Patient 14 14
Death 8 8
Hemorrhage/Bleeding 8 8
Exposure to Body Fluids 5 5
Pneumothorax 5 5
Laceration(s) 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Code Available 4 4
Pain 4 4
Aspiration/Inhalation 4 4
Cardiopulmonary Arrest 3 3
Device Embedded In Tissue or Plaque 3 3
Vomiting 3 3
Blood Loss 2 2
Complaint, Ill-Defined 2 2
Injury 2 2
Pulmonary Edema 2 2
Cardiac Arrest 2 2
Hearing Loss 2 2
Hematoma 2 2
Hemothorax 2 2
Unspecified Infection 2 2
Inflammation 1 1
Low Blood Pressure/ Hypotension 1 1
Bacterial Infection 1 1
Airway Obstruction 1 1
Anemia 1 1
Deposits 1 1
Dyspnea 1 1
Fall 1 1
Respiratory Distress 1 1
Ulcer 1 1
Discomfort 1 1
Liver Laceration(s) 1 1
Burn, Thermal 1 1
Not Applicable 1 1
Pleural Empyema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Jan-18-2024
2 Cardinal Health 200, LLC II Apr-30-2018
3 Hospira Inc. II Aug-18-2016
4 Hospira Inc. II Dec-06-2013
5 Stryker Corporation II Mar-02-2018
6 Stryker Endoscopy II May-03-2013
7 Synaptive Medical Inc II Jun-25-2021
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