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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 2540 3470

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 3651 3731
Mechanical Jam 2844 2844
Complete Loss of Power 2772 2772
Output below Specifications 1624 1624
Fracture 1597 2226
Break 1426 1456
Excessive Heating 1418 1418
Noise, Audible 1025 1025
Detachment of Device or Device Component 1000 1801
Appropriate Term/Code Not Available 789 789
Unintended System Motion 776 777
Failure to Cut 576 576
Intermittent Loss of Power 533 533
Overheating of Device 504 692
Device-Device Incompatibility 430 430
Fluid/Blood Leak 319 885
Device Remains Activated 241 854
Material Fragmentation 176 265
Unexpected Shutdown 175 175
Material Disintegration 166 443
Naturally Worn 164 164
Vibration 162 162
Material Twisted/Bent 160 160
Leak/Splash 157 157
Mechanical Problem 144 146
Device Slipped 141 141
Intermittent Energy Output 134 134
Premature Separation 118 118
Fail-Safe Did Not Operate 110 243
Entrapment of Device 109 109
Fail-Safe Problem 104 243
Flaked 102 1090
Material Deformation 84 85
Corroded 81 81
Crack 69 69
Adverse Event Without Identified Device or Use Problem 68 68
Defective Device 68 68
Difficult to Open or Close 60 255
Material Separation 56 56
Unintended Movement 47 47
Electrical /Electronic Property Problem 44 44
Material Integrity Problem 42 42
Energy Output Problem 42 42
Unintended Power Up 41 49
Dull, Blunt 38 38
Compatibility Problem 37 37
Smoking 30 30
Environmental Particulates 28 28
Material Split, Cut or Torn 27 27
Contamination /Decontamination Problem 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12361 16048
No Consequences Or Impact To Patient 4562 5319
No Known Impact Or Consequence To Patient 905 1301
No Patient Involvement 511 1561
Insufficient Information 444 583
Foreign Body In Patient 371 371
Device Embedded In Tissue or Plaque 112 112
Not Applicable 99 99
No Code Available 91 91
Burn(s) 50 50
No Information 42 106
Injury 31 31
Skin Tears 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Unspecified Tissue Injury 16 16
Bone Fracture(s) 15 15
Superficial (First Degree) Burn 10 10
Pain 9 9
Unspecified Infection 8 8
Failure of Implant 7 7
Tissue Damage 6 6
Laceration(s) 6 6
Abrasion 4 4
Burn, Thermal 4 4
Cardiac Perforation 4 4
Infiltration into Tissue 3 3
Brain Injury 3 3
Patient Problem/Medical Problem 3 3
Perforation 2 2
Skin Irritation 2 2
Hemorrhage/Bleeding 2 2
Full thickness (Third Degree) Burn 2 2
Alteration In Body Temperature 1 1
Skin Discoloration 1 2
Rupture 1 1
Nerve Damage 1 1
Sprain 1 1
Limb Fracture 1 1
Shock 1 1
Non-union Bone Fracture 1 1
Swelling/ Edema 1 1
Hypersensitivity/Allergic reaction 1 1
Arrhythmia 1 1
Damage to Ligament(s) 1 1
Hearing Impairment 1 1
Tinnitus 1 1

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