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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device drill, surgical, ent (electric or pneumatic) including handpiece
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
INTERSCOPE, 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
2019 2515 2515
2020 2369 2369
2021 2283 2283
2022 1574 1574
2023 1726 1726
2024 1104 1104

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 6717 6717
Excessive Heating 736 736
Detachment of Device or Device Component 687 687
Device Remains Activated 675 675
Output below Specifications 428 428
Fluid/Blood Leak 390 390
Noise, Audible 389 389
Vibration 367 367
Break 306 306
Fail-Safe Did Not Operate 240 240
Device Damaged by Another Device 217 217
Unintended System Motion 216 216
Unintended Power Up 215 215
Leak/Splash 202 202
Complete Loss of Power 192 192
Fracture 149 149
Flaked 132 132
Mechanical Jam 128 128
Appropriate Term/Code Not Available 109 109
Material Fragmentation 101 101
Device-Device Incompatibility 92 92
Material Twisted/Bent 91 91
Mechanical Problem 74 74
Fail-Safe Problem 60 60
Use of Device Problem 50 50
Unintended Movement 31 31
Difficult or Delayed Separation 29 29
Material Disintegration 28 28
Self-Activation or Keying 27 27
Component Missing 21 21
Intermittent Loss of Power 20 20
Material Separation 20 20
Premature Separation 20 20
Connection Problem 20 20
Physical Resistance/Sticking 17 17
Separation Problem 16 16
Smoking 16 16
Energy Output Problem 14 14
Display or Visual Feedback Problem 12 12
Device Alarm System 12 12
Defective Device 11 11
Incorrect Interpretation of Signal 11 11
Device Slipped 11 11
Unexpected Shutdown 11 11
Material Rupture 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Power Problem 10 10
Output Problem 9 9
Environmental Particulates 9 9
Unintended Ejection 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7835 7835
No Patient Involvement 2690 2690
No Consequences Or Impact To Patient 1349 1349
No Known Impact Or Consequence To Patient 257 257
Insufficient Information 114 114
Burn(s) 57 57
No Information 32 32
Superficial (First Degree) Burn 14 14
Partial thickness (Second Degree) Burn 12 12
Hemorrhage/Bleeding 9 9
Unspecified Tissue Injury 8 8
Foreign Body In Patient 5 5
Hearing Impairment 4 4
Unspecified Infection 3 3
Burn, Thermal 3 3
Bone Fracture(s) 2 2
Oversedation 2 2
Numbness 2 2
Eye Injury 2 2
Shock 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arrhythmia 1 1
Hypersensitivity/Allergic reaction 1 1
Fatigue 1 1
Radiation Exposure, Unintended 1 1
Not Applicable 1 1
Dizziness 1 1
Sinus Perforation 1 1
Abrasion 1 1
Scarring 1 1
Intracranial Hemorrhage 1 1
Nerve Damage 1 1
Laceration(s) 1 1
Pain 1 1
Visual Impairment 1 1
Cerebrospinal Fluid Leakage 1 1
Tissue Damage 1 1
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 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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