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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device drill, surgical, ent (electric or pneumatic) including handpiece
Regulation Description Ear, nose, and throat electric or pneumatic surgical drill.
Product CodeERL
Regulation Number 874.4250
Device Class 2


Premarket Reviews
ManufacturerDecision
BIEN-AIR SURGERY SA
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
W&H DENTALWERK BUERMOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZETHON LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2369 2369
2021 2283 2283
2022 1574 1574
2023 1726 1726
2024 1589 1589
2025 421 421

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 5337 5337
Excessive Heating 825 825
Device Remains Activated 662 662
Detachment of Device or Device Component 629 629
Vibration 486 486
Noise, Audible 391 391
Break 309 309
Device Damaged by Another Device 279 279
Output below Specifications 271 271
Fluid/Blood Leak 248 248
Fail-Safe Did Not Operate 239 239
Complete Loss of Power 217 217
Leak/Splash 196 196
Unintended Power Up 156 156
Fracture 150 150
Appropriate Term/Code Not Available 149 149
Mechanical Jam 138 138
Flaked 128 128
Unintended System Motion 126 126
Material Fragmentation 106 106
Device-Device Incompatibility 100 100
Mechanical Problem 56 56
Fail-Safe Problem 54 54
Use of Device Problem 42 42
Difficult or Delayed Separation 38 38
Material Twisted/Bent 33 33
Material Disintegration 28 28
Self-Activation or Keying 28 28
Premature Separation 25 25
Unintended Movement 22 22
Connection Problem 22 22
Component Missing 21 21
Intermittent Loss of Power 21 21
Physical Resistance/Sticking 19 19
Separation Problem 16 16
Incorrect Interpretation of Signal 16 16
Device Alarm System 15 15
Energy Output Problem 14 14
Smoking 14 14
Device Slipped 14 14
Environmental Particulates 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Defective Device 11 11
Output Problem 11 11
Display or Visual Feedback Problem 10 10
Power Problem 9 9
Device Reprocessing Problem 8 8
Material Frayed 8 8
Corroded 7 7
Unintended Ejection 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8594 8594
No Patient Involvement 943 943
No Consequences Or Impact To Patient 701 701
Insufficient Information 128 128
No Known Impact Or Consequence To Patient 51 51
Burn(s) 43 43
Superficial (First Degree) Burn 11 11
Partial thickness (Second Degree) Burn 9 9
Unspecified Tissue Injury 8 8
No Information 7 7
Hemorrhage/Bleeding 7 7
Foreign Body In Patient 5 5
Unspecified Infection 3 3
Burn, Thermal 3 3
Hearing Impairment 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Bone Fracture(s) 2 2
Nerve Damage 2 2
Numbness 2 2
Eye Injury 2 2
Shock 2 2
Arrhythmia 1 1
Hypersensitivity/Allergic reaction 1 1
Fatigue 1 1
Radiation Exposure, Unintended 1 1
Dizziness 1 1
Perforation 1 1
Sinus Perforation 1 1
Abrasion 1 1
Intracranial Hemorrhage 1 1
Oversedation 1 1
Laceration(s) 1 1
Pain 1 1
Visual Impairment 1 1
Cerebrospinal Fluid Leakage 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bien-Air Surgery Sa II Oct-21-2020
2 Medtronic Xomed, Inc. II Apr-20-2022
3 Medtronic Xomed, Inc. II Jul-21-2020
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