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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 837 837

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 6597 6597
Excessive Heating 711 711
Detachment of Device or Device Component 666 666
Device Remains Activated 666 666
Output below Specifications 424 424
Fluid/Blood Leak 385 385
Noise, Audible 376 376
Vibration 349 349
Break 285 285
Fail-Safe Did Not Operate 236 236
Unintended Power Up 208 208
Unintended System Motion 207 207
Device Damaged by Another Device 203 203
Leak/Splash 196 196
Complete Loss of Power 183 183
Fracture 144 144
Flaked 130 130
Mechanical Jam 123 123
Appropriate Term/Code Not Available 100 100
Material Fragmentation 100 100
Material Twisted/Bent 91 91
Device-Device Incompatibility 88 88
Mechanical Problem 73 73
Fail-Safe Problem 58 58
Use of Device Problem 47 47
Unintended Movement 31 31
Material Disintegration 27 27
Difficult or Delayed Separation 26 26
Self-Activation or Keying 25 25
Component Missing 21 21
Material Separation 20 20
Intermittent Loss of Power 20 20
Connection Problem 19 19
Smoking 16 16
Physical Resistance/Sticking 16 16
Premature Separation 16 16
Separation Problem 16 16
Energy Output Problem 14 14
Display or Visual Feedback Problem 12 12
Device Alarm System 12 12
Defective Device 11 11
Device Slipped 10 10
Incorrect Interpretation of Signal 10 10
Unexpected Shutdown 10 10
Power Problem 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Output Problem 9 9
Environmental Particulates 9 9
Material Rupture 9 9
Unstable 7 7
Device Reprocessing Problem 7 7
Collapse 6 6
Unintended Ejection 6 6
Corroded 6 6
Material Frayed 6 6
Loose or Intermittent Connection 6 6
Temperature Problem 6 6
Erratic or Intermittent Display 5 5
Intermittent Continuity 5 5
Sparking 4 4
Contamination /Decontamination Problem 4 4
Material Integrity Problem 4 4
Material Deformation 3 3
Patient Device Interaction Problem 3 3
Fitting Problem 3 3
Failure to Power Up 3 3
Computer Software Problem 3 3
Electrical /Electronic Property Problem 3 3
Delivered as Unsterile Product 3 3
Image Display Error/Artifact 2 2
Entrapment of Device 2 2
Crack 2 2
Degraded 2 2
Contamination 2 2
Complete Blockage 2 2
Inability to Irrigate 2 2
Ambient Noise Problem 2 2
Material Split, Cut or Torn 2 2
Intermittent Energy Output 2 2
No Apparent Adverse Event 2 2
Naturally Worn 2 2
Infusion or Flow Problem 2 2
Failure to Auto Stop 2 2
Electrical Power Problem 2 2
Device Markings/Labelling Problem 2 2
Difficult to Open or Close 1 1
Environmental Compatibility Problem 1 1
Compatibility Problem 1 1
Mechanics Altered 1 1
Insufficient Information 1 1
Unintended Electrical Shock 1 1
Activation Problem 1 1
Blocked Connection 1 1
Deformation Due to Compressive Stress 1 1
Patient-Device Incompatibility 1 1
Communication or Transmission Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Residue After Decontamination 1 1
Dull, Blunt 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7575 7575
No Patient Involvement 2690 2690
No Consequences Or Impact To Patient 1349 1349
No Known Impact Or Consequence To Patient 257 257
Insufficient Information 108 108
Burn(s) 56 56
No Information 32 32
Superficial (First Degree) Burn 13 13
Partial thickness (Second Degree) Burn 11 11
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
Oversedation 2 2
Shock 2 2
Bone Fracture(s) 2 2
Eye Injury 2 2
Fatigue 1 1
Cerebrospinal Fluid Leakage 1 1
Abrasion 1 1
Arrhythmia 1 1
Tissue Damage 1 1
Dizziness 1 1
Scarring 1 1
Laceration(s) 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sinus Perforation 1 1
Numbness 1 1
Full thickness (Third Degree) Burn 1 1
Radiation Exposure, Unintended 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 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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