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TPLC
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Device
apparatus, suction, operating-room, wall vacuum powered
Product Code
GCX
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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