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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
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHWE
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2020 3248 4035
2021 3140 3843
2022 3327 4019
2023 3399 4241
2024 3689 4962
2025 309 622

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 3776 3782
Complete Loss of Power 2977 2977
Mechanical Jam 2572 2572
Excessive Heating 1466 1466
Fracture 1368 2000
Break 1326 1332
Output below Specifications 984 984
Appropriate Term/Code Not Available 915 915
Detachment of Device or Device Component 896 1634
Noise, Audible 756 756
Failure to Cut 648 648
Unintended System Motion 610 611
Intermittent Loss of Power 552 552
Device-Device Incompatibility 436 436
Overheating of Device 287 429
Fluid/Blood Leak 239 742
Device Remains Activated 213 675
Mechanical Problem 206 207
Material Fragmentation 177 261
Naturally Worn 177 177
Material Disintegration 162 454
Leak/Splash 158 158
Device Slipped 156 156
Material Twisted/Bent 150 150
Vibration 142 142
Premature Separation 130 130
Fail-Safe Did Not Operate 120 346
Flaked 109 1360
Material Deformation 100 100
Entrapment of Device 99 99
Fail-Safe Problem 87 191
Corroded 79 79
Electrical /Electronic Property Problem 75 75
Defective Device 70 70
Adverse Event Without Identified Device or Use Problem 63 63
Difficult to Open or Close 54 206
Energy Output Problem 45 45
Crack 45 45
Unintended Movement 43 44
Material Integrity Problem 41 41
Compatibility Problem 36 36
Dull, Blunt 35 35
Unintended Power Up 31 37
Material Separation 30 30
Environmental Particulates 30 30
Material Split, Cut or Torn 29 29
Contamination /Decontamination Problem 28 28
Smoking 27 27
Component Missing 25 25
Device Reprocessing Problem 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13677 17976
No Consequences Or Impact To Patient 2274 2605
Insufficient Information 575 745
Foreign Body In Patient 337 338
No Patient Involvement 236 799
No Known Impact Or Consequence To Patient 153 254
Device Embedded In Tissue or Plaque 96 96
No Code Available 66 66
Burn(s) 41 41
Injury 26 26
Skin Tears 26 26
Not Applicable 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Unspecified Tissue Injury 16 16
No Information 15 28
Bone Fracture(s) 14 14
Superficial (First Degree) Burn 10 10
Unspecified Infection 6 6
Failure of Implant 6 6
Pain 5 5
Abrasion 4 4
Laceration(s) 4 4
Cardiac Perforation 4 4
Burn, Thermal 4 4
Brain Injury 3 3
Infiltration into Tissue 3 3
Full thickness (Third Degree) Burn 3 3
Tissue Damage 2 2
Perforation 2 2
Hemorrhage/Bleeding 2 2
Limb Fracture 1 1
Hypersensitivity/Allergic reaction 1 1
Hearing Impairment 1 1
Tinnitus 1 1
Nerve Damage 1 1
Swelling/ Edema 1 1
Rupture 1 1
Shock 1 1
Skin Discoloration 1 2
Patient Problem/Medical Problem 1 1
Arrhythmia 1 1
Non-union Bone Fracture 1 1

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