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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
2018 1288 1288
2019 1131 1131
2020 952 952
2021 1146 1146
2022 1361 1361
2023 467 467

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 1550 1550
Mechanical Jam 986 986
Complete Loss of Power 916 916
Unintended System Motion 694 694
Excessive Heating 653 653
Noise, Audible 423 423
Detachment of Device or Device Component 399 399
Fail-Safe Problem 256 256
Material Fragmentation 235 235
Intermittent Loss of Power 220 220
Device Alarm System 174 174
Output below Specifications 168 168
Appropriate Term/Code Not Available 161 161
Vibration 151 151
Intermittent Energy Output 142 142
Overheating of Device 138 138
Device-Device Incompatibility 137 137
Leak/Splash 134 134
Fluid/Blood Leak 129 129
Break 125 125
Unexpected Shutdown 111 111
Material Frayed 65 65
Fail-Safe Did Not Operate 63 63
Positioning Problem 62 62
Device Operates Differently Than Expected 57 57
Device Stops Intermittently 51 51
Fracture 49 49
Device Slipped 48 48
Mechanical Problem 41 41
Loose or Intermittent Connection 30 30
Device Inoperable 30 30
Premature Separation 28 28
Difficult or Delayed Separation 23 23
Adverse Event Without Identified Device or Use Problem 23 23
Connection Problem 23 23
Material Twisted/Bent 21 21
Device Reprocessing Problem 20 20
Detachment Of Device Component 19 19
Packaging Problem 17 17
Material Deformation 10 10
Circuit Failure 10 10
Difficult to Remove 10 10
Electrical /Electronic Property Problem 9 9
Environmental Particulates 9 9
Contamination /Decontamination Problem 8 8
Component Missing 8 8
Separation Failure 8 8
Incomplete or Inadequate Connection 8 8
Crack 7 7
Energy Output Problem 6 6
Device Contaminated During Manufacture or Shipping 6 6
Device Operational Issue 5 5
Difficult to Open or Close 4 4
Defective Component 4 4
Material Separation 4 4
Peeled/Delaminated 4 4
Difficult To Position 4 4
Corroded 4 4
Separation Problem 4 4
Failure to Clean Adequately 4 4
Power Problem 3 3
Unintended Movement 3 3
Premature Discharge of Battery 3 3
Difficult to Insert 3 3
Device Damaged by Another Device 3 3
Failure to Disconnect 3 3
Dent in Material 2 2
Device Markings/Labelling Problem 2 2
Electrical Shorting 2 2
Device Contamination with Chemical or Other Material 2 2
Use of Device Problem 2 2
Smoking 2 2
Suction Problem 2 2
Dull, Blunt 2 2
Positioning Failure 2 2
Loss of Power 2 2
Suction Failure 2 2
Naturally Worn 2 2
No Fail-Safe Mechanism 1 1
Operating System Becomes Nonfunctional 1 1
Pumping Problem 1 1
Reset Problem 1 1
Scratched Material 1 1
Temperature Problem 1 1
Mechanics Altered 1 1
Material Integrity Problem 1 1
Failure of Device to Self-Test 1 1
Unintended Electrical Shock 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Device Handling Problem 1 1
Explosion 1 1
Material Rupture 1 1
No Device Output 1 1
Particulates 1 1
Insufficient Heating 1 1
Melted 1 1
Intermittent Continuity 1 1
Complete Blockage 1 1
Air Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3089 3089
No Consequences Or Impact To Patient 2501 2501
No Known Impact Or Consequence To Patient 702 702
No Patient Involvement 15 15
Not Applicable 10 10
Bone Fracture(s) 9 9
Foreign Body In Patient 6 6
Injury 5 5
Burn(s) 4 4
No Code Available 4 4
Embolism/Embolus 4 4
Limb Fracture 4 4
Insufficient Information 3 3
Unspecified Tissue Injury 2 2
Abrasion 2 2
Unspecified Infection 2 2
Laceration(s) 2 2
Post Operative Wound Infection 2 2
Tissue Damage 2 2
Tingling 1 1
Superficial (First Degree) Burn 1 1
Electric Shock 1 1
Blood Loss 1 1
Nerve Damage 1 1
Skin Irritation 1 1
Hemorrhage/Bleeding 1 1
No Information 1 1
Partial thickness (Second Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Pro-Dex Inc II Aug-22-2019
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