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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tubing, noninvasive
Product CodeGAZ
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2018 10 10
2019 23 23
2020 25 25
2021 18 18
2022 12 12
2023 25 25
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 45 45
Suction Failure 9 9
Suction Problem 8 8
Break 4 4
Disconnection 4 4
Leak/Splash 4 4
Material Separation 3 3
Defective Device 3 3
Fitting Problem 3 3
Material Twisted/Bent 3 3
Device Contamination with Chemical or Other Material 3 3
Gas/Air Leak 3 3
Pressure Problem 3 3
Appropriate Term/Code Not Available 3 3
Noise, Audible 2 2
Material Rupture 2 2
Key or Button Unresponsive/not Working 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Integrity Problem 2 2
Fluid/Blood Leak 2 2
Filling Problem 2 2
Decrease in Suction 2 2
Backflow 1 1
Unintended Ejection 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Detachment Of Device Component 1 1
Failure to Conduct 1 1
Crack 1 1
Inability to Irrigate 1 1
Use of Device Problem 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Energy Output Problem 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
No Flow 1 1
Output Problem 1 1
Device Dislodged or Dislocated 1 1
Defective Component 1 1
Component Missing 1 1
Failure to Advance 1 1
Failure to Cut 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Insufficient Flow or Under Infusion 1 1
Separation Problem 1 1
Ejection Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76 76
No Consequences Or Impact To Patient 23 23
No Known Impact Or Consequence To Patient 14 14
No Patient Involvement 6 6
No Information 5 5
Insufficient Information 2 2
Foreign Body In Patient 1 1
Blood Loss 1 1
Pulmonary Embolism 1 1
Death 1 1
Pulmonary Emphysema 1 1
Hemorrhage/Bleeding 1 1
Swelling 1 1
Vitreous Hemorrhage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Minimally Invasive Therapies Group II Mar-05-2018
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