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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 instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Product CodeHWE
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 3452 4249
2020 3248 4035
2021 3140 3843
2022 3327 4019
2023 3399 4241
2024 328 605

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 3163 3243
Mechanical Jam 2534 2534
Complete Loss of Power 2394 2394
Output below Specifications 1596 1596
Fracture 1497 2100
Break 1226 1256
Excessive Heating 1225 1225
Noise, Audible 933 933
Detachment of Device or Device Component 888 1582
Unintended System Motion 727 727
Appropriate Term/Code Not Available 599 599
Failure to Cut 468 468
Intermittent Loss of Power 457 457
Overheating of Device 401 584
Device-Device Incompatibility 354 354
Fluid/Blood Leak 288 824
Device Remains Activated 220 802
Unexpected Shutdown 175 175
Vibration 156 156
Material Fragmentation 147 232
Material Disintegration 145 373
Leak/Splash 137 137
Material Twisted/Bent 135 135
Intermittent Energy Output 130 130
Naturally Worn 117 117
Fail-Safe Problem 103 242
Device Slipped 103 103
Premature Separation 103 103
Mechanical Problem 96 98
Entrapment of Device 96 96
Fail-Safe Did Not Operate 92 121
Flaked 89 790
Crack 68 68
Material Deformation 68 69
Adverse Event Without Identified Device or Use Problem 66 66
Material Separation 55 55
Corroded 50 50
Difficult to Open or Close 49 239
Defective Device 49 49
Unintended Power Up 40 48
Energy Output Problem 38 38
Unintended Movement 38 38
Material Integrity Problem 37 37
Dull, Blunt 37 37
Compatibility Problem 30 30
Smoking 27 27
Electrical /Electronic Property Problem 25 25
Environmental Particulates 23 23
Contamination /Decontamination Problem 23 23
Difficult or Delayed Separation 21 21
Difficult to Remove 19 19
Component Missing 18 18
Device Emits Odor 17 17
Device Reprocessing Problem 16 16
Connection Problem 15 15
Use of Device Problem 14 14
Degraded 14 14
Separation Problem 14 14
Positioning Failure 13 13
Device Markings/Labelling Problem 13 13
Material Split, Cut or Torn 13 13
Fire 12 12
Fitting Problem 12 12
Improper or Incorrect Procedure or Method 11 11
No Apparent Adverse Event 11 11
Power Problem 11 11
Device Damaged by Another Device 11 11
Defective Component 11 11
Protective Measures Problem 10 10
Insufficient Information 10 10
Circuit Failure 10 10
Key or Button Unresponsive/not Working 10 10
Unintended Ejection 9 10
Loose or Intermittent Connection 9 9
Packaging Problem 9 9
Output Problem 8 8
Difficult to Insert 8 8
Delivered as Unsterile Product 7 50
Positioning Problem 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Tear, Rip or Hole in Device Packaging 7 7
Separation Failure 6 6
Scratched Material 6 6
Temperature Problem 6 6
Failure to Cycle 6 6
Contamination 5 5
Display or Visual Feedback Problem 5 5
Failure to Power Up 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Failure to Auto Stop 5 5
Communication or Transmission Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Mechanics Altered 3 3
Device Handling Problem 3 3
Sparking 3 3
Structural Problem 3 3
Failure to Shut Off 3 3
Activation, Positioning or Separation Problem 3 3
Device Dislodged or Dislocated 3 3
Material Rupture 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10309 13344
No Consequences Or Impact To Patient 4562 5319
No Known Impact Or Consequence To Patient 905 1301
No Patient Involvement 511 1561
Foreign Body In Patient 341 341
Insufficient Information 269 377
Device Embedded In Tissue or Plaque 111 111
Not Applicable 99 99
No Code Available 91 91
Burn(s) 48 48
No Information 42 106
Injury 31 31
Skin Tears 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Unspecified Tissue Injury 15 15
Bone Fracture(s) 15 15
Superficial (First Degree) Burn 9 9
Pain 8 8
Failure of Implant 7 7
Unspecified Infection 7 7
Laceration(s) 6 6
Tissue Damage 6 6
Abrasion 4 4
Burn, Thermal 4 4
Cardiac Perforation 4 4
Brain Injury 3 3
Patient Problem/Medical Problem 3 3
Infiltration into Tissue 3 3
Hemorrhage/Bleeding 2 2
Skin Irritation 2 2
Perforation 2 2
Full thickness (Third Degree) Burn 2 2
Alteration In Body Temperature 1 1
Non-union Bone Fracture 1 1
Rupture 1 1
Shock 1 1
Skin Discoloration 1 2
Sprain 1 1
Tinnitus 1 1
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Arrhythmia 1 1
Hearing Impairment 1 1
Swelling/ Edema 1 1
Limb Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Jul-27-2019
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