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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
2018 204 204
2019 129 129
2020 100 100
2021 131 131
2022 229 229
2023 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Break 427 427
Material Separation 146 146
Vibration 139 139
Material Fragmentation 93 93
Mechanical Jam 24 24
Overheating of Device 21 21
Physical Resistance/Sticking 16 16
Use of Device Problem 15 15
Connection Problem 12 12
Adverse Event Without Identified Device or Use Problem 10 10
Device Markings/Labelling Problem 9 9
Mechanical Problem 9 9
Noise, Audible 7 7
Contamination /Decontamination Problem 6 6
Output Problem 5 5
Inability to Irrigate 5 5
Material Twisted/Bent 5 5
Unintended Movement 5 5
Loose or Intermittent Connection 3 3
Detachment of Device or Device Component 3 3
Obstruction of Flow 3 3
Defective Device 3 3
Fitting Problem 2 2
Failure to Power Up 2 2
Fracture 2 2
Unstable 2 2
No Apparent Adverse Event 2 2
Intermittent Loss of Power 1 1
Activation Problem 1 1
Self-Activation or Keying 1 1
Inadequacy of Device Shape and/or Size 1 1
Smoking 1 1
Stretched 1 1
Device Inoperable 1 1
Misconnection 1 1
No Device Output 1 1
Complete Blockage 1 1
Crack 1 1
Display or Visual Feedback Problem 1 1
Defective Component 1 1
Dull, Blunt 1 1
Blocked Connection 1 1
Device Operates Differently Than Expected 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 408 408
No Consequences Or Impact To Patient 340 340
No Known Impact Or Consequence To Patient 51 51
No Patient Involvement 21 21
Radiation Exposure, Unintended 10 10
Device Embedded In Tissue or Plaque 7 7
Burn(s) 7 7
Insufficient Information 7 7
Unintended Radiation Exposure 6 6
Foreign Body In Patient 6 6
Abrasion 5 5
Unspecified Tissue Injury 3 3
Bone Fracture(s) 3 3
Hearing Impairment 2 2
Oversedation 2 2
Eye Injury 2 2
Burn, Thermal 1 1
Partial thickness (Second Degree) Burn 1 1
No Information 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gyrus ACMI, Inc. II Mar-20-2018
2 Medtronic Xomed, Inc. II Oct-21-2021
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