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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
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
16
16
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
50
50
Delivered as Unsterile Product
50
50
Suction Failure
38
38
Fluid/Blood Leak
30
30
Leak/Splash
29
29
Detachment of Device or Device Component
28
28
Crack
26
26
Contamination /Decontamination Problem
25
25
Packaging 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
Residue After Decontamination
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Failure to Eject
7
7
Manufacturing, Packaging or Shipping Problem
6
6
Smoking
6
6
Collapse
5
5
Fracture
4
4
Material Separation
4
4
Material Puncture/Hole
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
Overheating of Device
3
3
Kinked
3
3
Improper or Incorrect Procedure or Method
3
3
Material Discolored
3
3
Thermal Decomposition of Device
3
3
Partial Blockage
2
2
Failure to Conduct
2
2
Unintended Ejection
2
2
Hole In Material
2
2
Loose or Intermittent Connection
2
2
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
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
Failure to Read Input Signal
1
1
Device Slipped
1
1
Problem with Sterilization
1
1
Sticking
1
1
Unexpected Therapeutic Results
1
1
Pacing Problem
1
1
Unsealed Device Packaging
1
1
Particulates
1
1
Loss of Power
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Reflux within Device
1
1
Device Remains Activated
1
1
Difficult to Remove
1
1
Battery Problem
1
1
Blocked Connection
1
1
Chemical Spillage
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
196
196
No Patient Involvement
61
61
Insufficient Information
58
58
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Pneumothorax
5
5
Exposure to Body Fluids
5
5
Laceration(s)
5
5
No Code Available
4
4
Aspiration/Inhalation
4
4
Pain
4
4
Device Embedded In Tissue or Plaque
3
3
Vomiting
3
3
Cardiopulmonary Arrest
3
3
Unspecified Infection
2
2
Injury
2
2
Blood Loss
2
2
Cardiac Arrest
2
2
Hematoma
2
2
Hearing Loss
2
2
Pulmonary Edema
2
2
Hemothorax
2
2
Complaint, Ill-Defined
2
2
Respiratory Distress
1
1
Ulcer
1
1
Airway Obstruction
1
1
Anemia
1
1
Inflammation
1
1
Not Applicable
1
1
Liver Laceration(s)
1
1
Pleural Empyema
1
1
Bacterial Infection
1
1
Dyspnea
1
1
Fall
1
1
Low Blood Pressure/ Hypotension
1
1
Deposits
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
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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