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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
Product CodeEQJ
Regulation Number 874.4140
Device Class 1

MDR Year MDR Reports MDR Events
2019 129 129
2020 100 100
2021 131 131
2022 229 229
2023 261 261
2024 178 178

Device Problems MDRs with this Device Problem Events in those MDRs
Break 604 604
Vibration 253 253
Material Separation 79 79
Physical Resistance/Sticking 66 66
Material Fragmentation 62 62
Mechanical Jam 39 39
Overheating of Device 19 19
Connection Problem 16 16
Noise, Audible 11 11
Mechanical Problem 10 10
Device Markings/Labelling Problem 9 9
Use of Device Problem 7 7
Contamination /Decontamination Problem 6 6
Material Twisted/Bent 6 6
Output Problem 5 5
Defective Device 3 3
Loose or Intermittent Connection 3 3
Fitting Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Fracture 2 2
Unintended Movement 2 2
Inadequacy of Device Shape and/or Size 2 2
Dull, Blunt 2 2
Inability to Irrigate 1 1
Failure to Disconnect 1 1
Failure to Align 1 1
Crack 1 1
Blocked Connection 1 1
Collapse 1 1
No Device Output 1 1
Detachment of Device or Device Component 1 1
Material Deformation 1 1
Failure to Power Up 1 1
Intermittent Loss of Power 1 1
Material Integrity Problem 1 1
Contamination 1 1
Misconnection 1 1
Defective Component 1 1
Smoking 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 808 808
No Consequences Or Impact To Patient 176 176
No Known Impact Or Consequence To Patient 18 18
No Patient Involvement 11 11
Unintended Radiation Exposure 8 8
Insufficient Information 7 7
Radiation Exposure, Unintended 7 7
Device Embedded In Tissue or Plaque 7 7
Unspecified Tissue Injury 5 5
Foreign Body In Patient 3 3
Bone Fracture(s) 3 3
Oversedation 2 2
Burn(s) 2 2
Eye Injury 2 2
Superficial (First Degree) Burn 1 1
Burn, Thermal 1 1

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