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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
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
W&H DENTALWERK BUERMOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1380 3606
2019 2515 2515
2020 2369 2369
2021 2283 2283
2022 1576 1576
2023 233 233

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 6134 7922
Device Remains Activated 631 661
Output below Specifications 581 581
Detachment of Device or Device Component 555 657
Excessive Heating 461 461
Fluid/Blood Leak 399 421
Noise, Audible 342 342
Unintended System Motion 307 307
Vibration 261 261
Break 234 238
Unintended Power Up 194 244
Leak/Splash 191 215
Fail-Safe Did Not Operate 175 175
Fail-Safe Problem 134 141
Flaked 128 136
Complete Loss of Power 117 117
Fracture 105 119
Material Twisted/Bent 104 137
Mechanical Jam 99 99
Material Fragmentation 95 111
Device Damaged by Another Device 92 92
Device-Device Incompatibility 64 64
Mechanical Problem 61 61
Appropriate Term/Code Not Available 43 43
Use of Device Problem 36 36
Disassembly 32 102
Unintended Movement 31 31
Material Separation 27 27
Smoking 25 29
Material Disintegration 24 29
Component Missing 21 21
Self-Activation or Keying 19 19
Physical Resistance/Sticking 18 27
Connection Problem 16 16
Material Rupture 14 14
Energy Output Problem 14 14
Intermittent Loss of Power 13 13
Separation Problem 11 11
Defective Device 11 11
Display or Visual Feedback Problem 11 11
Unstable 10 11
Difficult or Delayed Separation 9 9
Unexpected Shutdown 9 9
Output Problem 9 9
Power Problem 8 8
Unintended Ejection 8 8
Device Reprocessing Problem 7 7
Loose or Intermittent Connection 7 7
Collapse 6 6
Intermittent Continuity 6 6
Corroded 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Premature Separation 6 6
Device Operates Differently Than Expected 6 6
Environmental Particulates 6 6
Temperature Problem 5 5
Device Alarm System 5 5
Bent 5 44
Device Slipped 5 5
Failure to Power Up 4 4
Material Frayed 4 4
Sparking 4 4
Fitting Problem 3 3
Contamination /Decontamination Problem 3 3
Material Integrity Problem 3 3
Infusion or Flow Problem 3 3
Positioning Problem 3 13
Difficult To Position 3 3
Delivered as Unsterile Product 3 3
Metal Shedding Debris 3 5
Air Leak 2 2
Inability to Irrigate 2 2
Electrical /Electronic Property Problem 2 2
Detachment Of Device Component 2 3
Complete Blockage 2 2
Computer Software Problem 2 2
No Apparent Adverse Event 2 2
Material Deformation 2 2
Failure to Auto Stop 2 2
Device Operational Issue 2 2
Device Markings/Labelling Problem 2 2
Defective Component 2 2
Ambient Noise Problem 2 2
Blocked Connection 1 1
Deformation Due to Compressive Stress 1 1
Patient-Device Incompatibility 1 1
Device Or Device Fragments Location Unknown 1 1
Contamination of Device Ingredient or Reagent 1 1
Delamination 1 1
Compatibility Problem 1 1
Device Packaging Compromised 1 1
Difficult to Open or Close 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Environmental Compatibility Problem 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
Insufficient Information 1 1
Intermittent Energy Output 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5310 5310
No Patient Involvement 3292 4216
No Consequences Or Impact To Patient 1897 2474
No Known Impact Or Consequence To Patient 503 1151
Burn(s) 54 250
Insufficient Information 40 40
No Information 38 42
Partial thickness (Second Degree) Burn 8 8
Therapeutic Effects, Unexpected 7 7
Superficial (First Degree) Burn 6 25
Hemorrhage/Bleeding 5 5
Foreign Body In Patient 4 4
Burn, Thermal 4 19
Unspecified Tissue Injury 4 4
Hearing Impairment 3 3
Bone Fracture(s) 2 2
Tissue Damage 2 2
Oversedation 2 2
Scarring 1 1
Shock 1 1
Intracranial Hemorrhage 1 1
Unspecified Infection 1 1
Cerebrospinal Fluid Leakage 1 1
Eye Injury 1 1
Abrasion 1 1
Arrhythmia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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