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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
2017 2119 2119
2018 1288 1288
2019 1131 1131
2020 952 952
2021 1146 1146
2022 1088 1088

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 1698 1698
Mechanical Jam 1418 1418
Physical Resistance/Sticking 1274 1274
Fail-Safe Problem 1273 1273
Complete Loss of Power 677 677
Excessive Heating 521 521
Noise, Audible 470 470
Detachment of Device or Device Component 357 357
Device Operates Differently Than Expected 252 252
Overheating of Device 228 228
Material Fragmentation 205 205
Fluid/Blood Leak 203 203
Intermittent Loss of Power 186 186
Intermittent Energy Output 142 142
Device Alarm System 141 141
Leak/Splash 123 123
Vibration 122 122
Device Inoperable 119 119
Unexpected Shutdown 111 111
Output below Specifications 108 108
Device-Device Incompatibility 105 105
Break 105 105
Mechanical Problem 98 98
Appropriate Term/Code Not Available 75 75
Device Stops Intermittently 63 63
Positioning Problem 62 62
Material Frayed 45 45
Detachment Of Device Component 44 44
Fail-Safe Did Not Operate 42 42
Fracture 41 41
Loose or Intermittent Connection 31 31
Device Slipped 31 31
Premature Separation 24 24
Material Twisted/Bent 22 22
Device Operational Issue 22 22
Connection Problem 21 21
Adverse Event Without Identified Device or Use Problem 21 21
Difficult to Remove 19 19
Difficult To Position 18 18
Defective Component 17 17
Component Missing 16 16
Packaging Problem 15 15
Difficult or Delayed Separation 13 13
Device Reprocessing Problem 12 12
Material Deformation 11 11
Circuit Failure 9 9
Crack 9 9
Contamination /Decontamination Problem 8 8
Incomplete or Inadequate Connection 8 8
No Fail-Safe Mechanism 7 7
Separation Failure 7 7
Difficult to Insert 6 6
Energy Output Problem 5 5
Electrical /Electronic Property Problem 5 5
Air Leak 5 5
Environmental Particulates 5 5
Device Contaminated During Manufacture or Shipping 5 5
Separation Problem 4 4
Difficult to Open or Close 4 4
Failure to Disconnect 4 4
Peeled/Delaminated 4 4
Material Separation 4 4
Smoking 4 4
Device Damaged by Another Device 3 3
Corroded 3 3
Material Disintegration 3 3
Loss of Power 3 3
Failure to Clean Adequately 3 3
Power Problem 3 3
Device Contamination with Chemical or Other Material 2 2
Naturally Worn 2 2
Suction Failure 2 2
Failure to Power Up 2 2
No Device Output 2 2
Fire 2 2
Dent in Material 2 2
Dull, Blunt 2 2
Use of Device Problem 2 2
Suction Problem 2 2
Fitting Problem 1 1
Failure to Advance 1 1
Unraveled Material 1 1
Material Rupture 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Markings/Labelling Problem 1 1
Electrical Shorting 1 1
Failure of Device to Self-Test 1 1
Fail-Safe Design Failure 1 1
Unintended Ejection 1 1
Decrease in Suction 1 1
Positioning Failure 1 1
Disassembly 1 1
Component Falling 1 1
Intermittent Continuity 1 1
Complete Blockage 1 1
Particulates 1 1
Insufficient Heating 1 1
Hole In Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2713 2713
No Clinical Signs, Symptoms or Conditions 2354 2354
No Patient Involvement 1336 1336
No Known Impact Or Consequence To Patient 1275 1275
Not Applicable 10 10
Bone Fracture(s) 9 9
Injury 6 6
Foreign Body In Patient 6 6
Device Embedded In Tissue or Plaque 5 5
No Information 5 5
No Code Available 5 5
Burn(s) 5 5
Embolism/Embolus 4 4
Limb Fracture 3 3
Unspecified Tissue Injury 2 2
Insufficient Information 2 2
Abrasion 2 2
Tissue Damage 2 2
Post Operative Wound Infection 2 2
Laceration(s) 2 2
Nerve Damage 1 1
Pain 1 1
Skin Irritation 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Electric Shock 1 1
Blood Loss 1 1
Reaction 1 1
Vertigo 1 1
Tingling 1 1
Partial thickness (Second Degree) Burn 1 1
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Apr-24-2017
2 Pro-Dex Inc II Aug-22-2019
3 The Anspach Effort, Inc. II May-04-2017
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