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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bur, ear, nose and throat
Regulation Description Ear, nose, and throat bur.
Product CodeEQJ
Regulation Number 874.4140
Device Class 1

MDR Year MDR Reports MDR Events
2020 100 100
2021 131 131
2022 229 229
2023 261 261
2024 368 368
2025 297 297

Device Problems MDRs with this Device Problem Events in those MDRs
Break 809 809
Vibration 460 460
Physical Resistance/Sticking 104 104
Mechanical Jam 69 69
Material Fragmentation 46 46
Material Separation 42 42
Connection Problem 25 25
Noise, Audible 17 17
Overheating of Device 12 12
Mechanical Problem 10 10
Use of Device Problem 9 9
Material Twisted/Bent 8 8
Device Markings/Labelling Problem 7 7
Output Problem 5 5
Fitting Problem 4 4
Failure to Cut 4 4
Defective Device 3 3
Difficult to Insert 3 3
Dull, Blunt 2 2
Unintended Movement 2 2
Fracture 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Deformation 2 2
No Device Output 1 1
Intermittent Loss of Power 1 1
Failure to Disconnect 1 1
No Apparent Adverse Event 1 1
Detachment of Device or Device Component 1 1
Misconnection 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Mechanics Altered 1 1
Blocked Connection 1 1
Failure to Align 1 1
Failure to Power Up 1 1
Contamination /Decontamination Problem 1 1
Contamination 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Defective Component 1 1
Smoking 1 1
Inability to Irrigate 1 1
Collapse 1 1
Suction Failure 1 1
Crack 1 1
Activation Problem 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1283 1283
No Consequences Or Impact To Patient 66 66
Insufficient Information 20 20
No Patient Involvement 11 11
Unintended Radiation Exposure 9 9
Unspecified Tissue Injury 6 6
Device Embedded In Tissue or Plaque 6 6
No Known Impact Or Consequence To Patient 4 4
Radiation Exposure, Unintended 3 3
Bone Fracture(s) 3 3
Foreign Body In Patient 3 3
Oversedation 2 2
Eye Injury 2 2
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Xomed, Inc. II Sep-12-2024
2 Medtronic Xomed, Inc. II Oct-21-2021
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