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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device saw, powered, and accessories
Product CodeHAB
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 676 676
2020 1462 1462
2021 1719 1719
2022 387 387
2023 734 734
2024 226 226

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2426 2426
Mechanical Jam 1681 1681
Protective Measures Problem 357 357
Mechanical Problem 242 242
Flaked 140 140
Noise, Audible 139 139
Insufficient Information 119 119
Break 94 94
No Apparent Adverse Event 63 63
Material Fragmentation 59 59
Communication or Transmission Problem 53 53
Physical Resistance/Sticking 48 48
Electrical Shorting 46 46
Material Separation 38 38
Connection Problem 28 28
Unintended Power Up 28 28
Failure to Power Up 26 26
Self-Activation or Keying 26 26
Electrical /Electronic Property Problem 25 25
Adverse Event Without Identified Device or Use Problem 25 25
Temperature Problem 22 22
Smoking 22 22
Detachment of Device or Device Component 22 22
Material Deformation 20 20
Key or Button Unresponsive/not Working 19 19
Corroded 18 18
Activation Problem 16 16
Appropriate Term/Code Not Available 15 15
Device Displays Incorrect Message 15 15
Unexpected Shutdown 13 13
Activation Failure 12 12
Device Markings/Labelling Problem 11 11
Melted 10 10
Therapeutic or Diagnostic Output Failure 9 9
Material Twisted/Bent 9 9
Output below Specifications 9 9
Intermittent Energy Output 9 9
Output Problem 8 8
Dull, Blunt 8 8
Defective Component 7 7
Circuit Failure 7 7
Fluid/Blood Leak 7 7
Material Integrity Problem 7 7
Power Problem 7 7
Unintended Movement 6 6
Material Frayed 6 6
Image Display Error/Artifact 6 6
Device Remains Activated 6 6
Device Emits Odor 6 6
Defective Device 6 6
Failure to Shut Off 6 6
Device Contaminated During Manufacture or Shipping 5 5
Sparking 5 5
Loss of Power 5 5
Display or Visual Feedback Problem 5 5
Fracture 5 5
Vibration 4 4
Component Missing 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device-Device Incompatibility 3 3
Contamination /Decontamination Problem 3 3
Suction Problem 3 3
Material Discolored 3 3
Crack 3 3
Delivered as Unsterile Product 3 3
Leak/Splash 3 3
Packaging Problem 3 3
Intermittent Loss of Power 3 3
Firing Problem 2 2
Material Opacification 2 2
Energy Output Problem 2 2
Peeled/Delaminated 2 2
Complete Blockage 2 2
Component Incompatible 2 2
Thermal Decomposition of Device 2 2
Unintended Ejection 2 2
Failure to Cut 2 2
Blocked Connection 2 2
Activation, Positioning or Separation Problem 2 2
Failure to Auto Stop 2 2
Device Dislodged or Dislocated 1 1
Failure to Fire 1 1
Ambient Noise Problem 1 1
Battery Problem 1 1
Failure to Align 1 1
Separation Failure 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Fire 1 1
Intermittent Continuity 1 1
Decoupling 1 1
Degraded 1 1
Failure to Run on Battery 1 1
Material Rupture 1 1
Premature Activation 1 1
Product Quality Problem 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3251 3251
No Patient Involvement 852 852
No Known Impact Or Consequence To Patient 813 813
No Information 170 170
Foreign Body In Patient 40 40
No Consequences Or Impact To Patient 36 36
Insufficient Information 30 30
Burn(s) 14 14
Injury 10 10
Unspecified Infection 3 3
Partial thickness (Second Degree) Burn 3 3
Device Embedded In Tissue or Plaque 3 3
Patient Problem/Medical Problem 2 2
Burn, Thermal 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Capsular Contracture 2 2
Hemorrhage/Bleeding 2 2
Pain 2 2
Loss of Range of Motion 2 2
Scar Tissue 1 1
Intracranial Hemorrhage 1 1
Forced Expiratory Volume Decreased 1 1
Post Operative Wound Infection 1 1
Rupture 1 1
Eye Injury 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Inflammation 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Metal Related Pathology 1 1
Blister 1 1
Unspecified Tissue Injury 1 1
Adhesion(s) 1 1
Fibrosis 1 1
Full thickness (Third Degree) Burn 1 1

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