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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, surgical instrument, ac-powered
Product CodeGEY
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 1131 1131
2020 952 952
2021 1145 1145
2022 1360 1360
2023 1437 1437
2024 124 124

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 1978 1978
Complete Loss of Power 1241 1241
Excessive Heating 801 801
Mechanical Jam 659 659
Unintended System Motion 492 492
Detachment of Device or Device Component 408 408
Noise, Audible 363 363
Appropriate Term/Code Not Available 308 308
Intermittent Loss of Power 287 287
Device Alarm System 266 266
Material Fragmentation 265 265
Vibration 189 189
Output below Specifications 185 185
Device-Device Incompatibility 180 180
Break 167 167
Leak/Splash 156 156
Fail-Safe Did Not Operate 111 111
Intermittent Energy Output 103 103
Material Frayed 95 95
Unexpected Shutdown 83 83
Overheating of Device 67 67
Device Slipped 67 67
Fracture 60 60
Fluid/Blood Leak 59 59
Positioning Problem 57 57
Fail-Safe Problem 52 52
Premature Separation 39 39
Mechanical Problem 34 34
Difficult or Delayed Separation 29 29
Device Reprocessing Problem 26 26
Adverse Event Without Identified Device or Use Problem 25 25
Packaging Problem 17 17
Loose or Intermittent Connection 15 15
Circuit Failure 14 14
Component Missing 14 14
Environmental Particulates 13 13
Separation Failure 12 12
Electrical /Electronic Property Problem 12 12
Material Twisted/Bent 9 9
Device Contaminated During Manufacture or Shipping 9 9
Difficult to Remove 7 7
Energy Output Problem 6 6
Corroded 6 6
Crack 6 6
Connection Problem 6 6
Difficult to Open or Close 4 4
Unintended Movement 4 4
Improper or Incorrect Procedure or Method 4 4
Suction Failure 4 4
Separation Problem 4 4
Premature Discharge of Battery 3 3
Positioning Failure 3 3
Fire 3 3
Material Deformation 3 3
Device Markings/Labelling Problem 3 3
Device Damaged by Another Device 3 3
Contamination /Decontamination Problem 3 3
Use of Device Problem 2 2
Compatibility Problem 2 2
Unintended Ejection 2 2
Suction Problem 2 2
Difficult to Insert 2 2
Peeled/Delaminated 2 2
Failure to Clean Adequately 2 2
Unintended Electrical Shock 1 1
Material Rupture 1 1
Device Damaged Prior to Use 1 1
Particulates 1 1
Melted 1 1
Insufficient Heating 1 1
Decrease in Suction 1 1
Intermittent Continuity 1 1
Infusion or Flow Problem 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
No Apparent Adverse Event 1 1
Explosion 1 1
Pumping Problem 1 1
Scratched Material 1 1
Electrical Shorting 1 1
Failure to Cut 1 1
Device Displays Incorrect Message 1 1
Battery Problem 1 1
Chemical Problem 1 1
Dull, Blunt 1 1
Dent in Material 1 1
Unraveled Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4175 4175
No Consequences Or Impact To Patient 1586 1586
No Known Impact Or Consequence To Patient 350 350
Bone Fracture(s) 9 9
Foreign Body In Patient 6 6
Injury 5 5
Unspecified Tissue Injury 5 5
No Code Available 4 4
Embolism/Embolus 4 4
Limb Fracture 4 4
Burn(s) 4 4
Not Applicable 3 3
Insufficient Information 3 3
Abrasion 2 2
Tissue Damage 2 2
Unspecified Infection 2 2
Laceration(s) 1 1
Nerve Damage 1 1
Skin Irritation 1 1
Tingling 1 1
Partial thickness (Second Degree) Burn 1 1
Post Operative Wound Infection 1 1
Electric Shock 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Superficial (First Degree) Burn 1 1
Unspecified Musculoskeletal problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Pro-Dex Inc II Jul-05-2023
2 Pro-Dex Inc II Aug-22-2019
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