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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 595 595

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 6488 6488
Excessive Heating 684 684
Device Remains Activated 651 651
Detachment of Device or Device Component 635 635
Output below Specifications 422 422
Fluid/Blood Leak 380 380
Noise, Audible 365 365
Vibration 336 336
Break 282 282
Fail-Safe Did Not Operate 234 234
Unintended System Motion 205 205
Unintended Power Up 203 203
Device Damaged by Another Device 195 195
Leak/Splash 192 192
Complete Loss of Power 178 178
Fracture 137 137
Flaked 130 130
Mechanical Jam 119 119
Material Fragmentation 97 97
Material Twisted/Bent 91 91
Appropriate Term/Code Not Available 90 90
Device-Device Incompatibility 86 86
Mechanical Problem 73 73
Fail-Safe Problem 58 58
Use of Device Problem 44 44
Unintended Movement 29 29
Material Disintegration 25 25
Self-Activation or Keying 24 24
Difficult or Delayed Separation 24 24
Component Missing 21 21
Material Separation 20 20
Connection Problem 19 19
Intermittent Loss of Power 19 19
Physical Resistance/Sticking 16 16
Smoking 16 16
Separation Problem 15 15
Premature Separation 14 14
Energy Output Problem 14 14
Display or Visual Feedback Problem 12 12
Defective Device 11 11
Device Slipped 10 10
Device Alarm System 10 10
Unexpected Shutdown 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Power Problem 10 10
Output Problem 9 9
Material Rupture 9 9
Environmental Particulates 8 8
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
Incorrect Interpretation of Signal 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
Failure to Power Up 3 3
Fitting 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
Computer Software Problem 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
No Apparent Adverse Event 2 2
Infusion or Flow Problem 2 2
Naturally Worn 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
Intermittent Energy Output 1 1
Activation Problem 1 1
Blocked Connection 1 1
Deformation Due to Compressive Stress 1 1
Patient-Device Incompatibility 1 1
Contamination of Device Ingredient or Reagent 1 1
Residue After Decontamination 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7341 7341
No Patient Involvement 2690 2690
No Consequences Or Impact To Patient 1349 1349
No Known Impact Or Consequence To Patient 257 257
Insufficient Information 99 99
Burn(s) 55 55
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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