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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dermatome
Product CodeGFD
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 472 472
2020 433 433
2021 614 614
2022 545 545
2023 810 810
2024 204 204

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1066 1066
Power Problem 381 381
Unstable 338 338
Patient Device Interaction Problem 248 248
Intermittent Loss of Power 243 243
Gas/Air Leak 212 212
Appropriate Term/Code Not Available 169 169
Material Frayed 155 155
Calibration Problem 132 132
Mechanical Problem 109 109
Component Missing 85 85
Noise, Audible 82 82
Incorrect, Inadequate or Imprecise Result or Readings 81 81
Material Deformation 76 76
Failure to Power Up 75 75
Loss of Power 69 69
Output Problem 63 63
Naturally Worn 61 61
Corroded 57 57
Break 51 51
Insufficient Information 51 51
Physical Resistance/Sticking 48 48
Loose or Intermittent Connection 48 48
Fitting Problem 45 45
Electrical /Electronic Property Problem 42 42
Adverse Event Without Identified Device or Use Problem 32 32
Incorrect Measurement 31 31
Output below Specifications 30 30
Positioning Problem 24 24
Material Integrity Problem 23 23
Structural Problem 22 22
Material Twisted/Bent 21 21
Material Split, Cut or Torn 20 20
Vibration 19 19
Detachment of Device or Device Component 14 14
Electrical Power Problem 14 14
Dull, Blunt 13 13
Overheating of Device 11 11
Activation Problem 10 10
Pressure Problem 10 10
Fluid/Blood Leak 8 8
Degraded 7 7
Failure to Calibrate 7 7
Unexpected Shutdown 7 7
Complete Loss of Power 6 6
Connection Problem 6 6
Misassembled 6 6
Defective Device 5 5
Electrical Shorting 5 5
Failure to Shut Off 5 5
Improper or Incorrect Procedure or Method 5 5
Use of Device Problem 5 5
Mechanical Jam 5 5
Temperature Problem 4 4
Excessive Heating 4 4
Material Puncture/Hole 4 4
Defective Component 4 4
Difficult to Remove 3 3
Device Damaged Prior to Use 3 3
Improper Flow or Infusion 3 3
Leak/Splash 3 3
Output above Specifications 3 3
Positioning Failure 3 3
Circuit Failure 3 3
Therapeutic or Diagnostic Output Failure 3 3
Misassembly by Users 2 2
Mechanics Altered 2 2
Unintended Power Up 2 2
Gel Leak 2 2
Imprecision 2 2
Delivered as Unsterile Product 2 2
Off-Label Use 2 2
Difficult to Open or Close 2 2
Expulsion 2 2
Malposition of Device 2 2
Unexpected Therapeutic Results 2 2
Failure to Disconnect 2 2
Obstruction of Flow 1 1
Failure to Deliver 1 1
Tear, Rip or Hole in Device Packaging 1 1
Sparking 1 1
Activation, Positioning or Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Human-Device Interface Problem 1 1
Material Too Rigid or Stiff 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Smoking 1 1
Problem with Sterilization 1 1
Device Emits Odor 1 1
Unintended System Motion 1 1
Energy Output Problem 1 1
Difficult to Insert 1 1
Fracture 1 1
Flaked 1 1
Restricted Flow rate 1 1
Device Reprocessing Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1842 1842
No Patient Involvement 332 332
No Consequences Or Impact To Patient 263 263
Laceration(s) 223 223
No Known Impact Or Consequence To Patient 219 219
Abrasion 175 175
Insufficient Information 67 67
Unspecified Tissue Injury 42 42
No Code Available 42 42
Scar Tissue 15 15
Injury 15 15
Localized Skin Lesion 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Skin Tears 5 5
Physical Asymmetry 4 4
Muscle/Tendon Damage 4 4
No Information 3 3
Suture Abrasion 3 3
Burn(s) 3 3
Scarring 2 2
Tissue Damage 2 2
Failure of Implant 2 2
Impaired Healing 2 2
Patient Problem/Medical Problem 2 2
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
Sedation 1 1
Wrinkling 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
Pain 1 1
Crushing Injury 1 1
Hematoma 1 1
Adhesion(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Sep-12-2020
2 Zimmer Surgical Inc II Oct-06-2023
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