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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


Premarket Reviews
ManufacturerDecision
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 95 95
2015 93 93
2016 95 95
2017 118 118
2018 204 204
2019 129 129
2020 100 100
2021 131 131
2022 229 229
2023 261 261
2024 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Break 857 857
Material Fragmentation 260 260
Vibration 242 242
Material Separation 152 152
Physical Resistance/Sticking 61 61
Overheating of Device 45 45
Mechanical Jam 40 40
Adverse Event Without Identified Device or Use Problem 24 24
Use of Device Problem 16 16
Connection Problem 15 15
Mechanical Problem 12 12
Fracture 9 9
Device Markings/Labelling Problem 9 9
Noise, Audible 9 9
Unintended Movement 6 6
Contamination /Decontamination Problem 6 6
Material Twisted/Bent 6 6
Inability to Irrigate 6 6
Stretched 6 6
Unintended System Motion 5 5
Detachment Of Device Component 5 5
Material Deformation 5 5
Output Problem 5 5
Device Operates Differently Than Expected 5 5
Detachment of Device or Device Component 4 4
Fitting Problem 4 4
Component Falling 4 4
Complete Blockage 3 3
Device Inoperable 3 3
Loose or Intermittent Connection 3 3
Obstruction of Flow 3 3
Defective Device 3 3
Material Integrity Problem 2 2
No Apparent Adverse Event 2 2
Unstable 2 2
Inadequacy of Device Shape and/or Size 2 2
Smoking 2 2
Failure to Power Up 2 2
Off-Label Use 2 2
Thermal Decomposition of Device 2 2
Leak/Splash 2 2
Misconnection 1 1
Device Emits Odor 1 1
Burst Container or Vessel 1 1
Contamination 1 1
Crack 1 1
Degraded 1 1
Display or Visual Feedback Problem 1 1
Unintended Ejection 1 1
Flaked 1 1
Device Appears to Trigger Rejection 1 1
Self-Activation or Keying 1 1
No Device Output 1 1
Unexpected Therapeutic Results 1 1
Metal Shedding Debris 1 1
Suction Problem 1 1
Device Handling Problem 1 1
Naturally Worn 1 1
Intermittent Loss of Power 1 1
Activation Problem 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Blocked Connection 1 1
Device Contamination With Biological Material 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Align 1 1
Failure to Disconnect 1 1
Failure to Cut 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Component Missing 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 762 762
No Consequences Or Impact To Patient 543 543
No Known Impact Or Consequence To Patient 179 179
No Patient Involvement 27 27
Foreign Body In Patient 24 24
Radiation Exposure, Unintended 23 23
Device Embedded In Tissue or Plaque 13 13
No Code Available 8 8
Unintended Radiation Exposure 8 8
Burn(s) 8 8
Insufficient Information 7 7
Unspecified Tissue Injury 5 5
No Information 5 5
Abrasion 5 5
Tissue Damage 5 5
Burn, Thermal 4 4
Hemorrhage/Bleeding 4 4
Bone Fracture(s) 3 3
Injury 3 3
Hearing Impairment 2 2
Partial thickness (Second Degree) Burn 2 2
Low Oxygen Saturation 2 2
Eye Injury 2 2
Cerebrospinal Fluid Leakage 2 2
Oversedation 2 2
Perforation 1 1
Pneumothorax 1 1
Swelling 1 1
Hemostasis 1 1
Unspecified Infection 1 1
Nerve Damage 1 1
Exsanguination 1 1
Cellulitis 1 1
Feeding Problem 1 1
Headache 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Superficial (First Degree) Burn 1 1
Vertigo 1 1
Nasal Obstruction 1 1
Discharge 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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