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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 100 100

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1029 1029
Power Problem 374 374
Unstable 321 321
Intermittent Loss of Power 239 239
Patient Device Interaction Problem 235 235
Gas/Air Leak 202 202
Appropriate Term/Code Not Available 157 157
Material Frayed 154 154
Calibration Problem 130 130
Mechanical Problem 109 109
Component Missing 84 84
Incorrect, Inadequate or Imprecise Result or Readings 81 81
Noise, Audible 79 79
Material Deformation 74 74
Failure to Power Up 74 74
Loss of Power 69 69
Output Problem 63 63
Naturally Worn 60 60
Corroded 55 55
Break 47 47
Loose or Intermittent Connection 46 46
Insufficient Information 46 46
Physical Resistance/Sticking 46 46
Fitting Problem 45 45
Electrical /Electronic Property Problem 42 42
Adverse Event Without Identified Device or Use Problem 32 32
Output below Specifications 30 30
Incorrect Measurement 30 30
Structural Problem 22 22
Material Integrity Problem 22 22
Positioning Problem 22 22
Material Twisted/Bent 19 19
Vibration 19 19
Material Split, Cut or Torn 18 18
Electrical Power Problem 14 14
Detachment of Device or Device Component 13 13
Dull, Blunt 13 13
Pressure Problem 10 10
Overheating of Device 9 9
Fluid/Blood Leak 8 8
Activation Problem 8 8
Degraded 7 7
Failure to Calibrate 7 7
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
Complete Loss of Power 5 5
Mechanical Jam 5 5
Temperature Problem 4 4
Unexpected Shutdown 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 1752 1752
No Patient Involvement 332 332
No Consequences Or Impact To Patient 263 263
No Known Impact Or Consequence To Patient 219 219
Laceration(s) 210 210
Abrasion 175 175
Insufficient Information 65 65
No Code Available 42 42
Unspecified Tissue Injury 41 41
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
Burn(s) 3 3
Suture Abrasion 3 3
No Information 3 3
Patient Problem/Medical Problem 2 2
Scarring 2 2
Tissue Damage 2 2
Failure of Implant 2 2
Impaired Healing 2 2
Full thickness (Third Degree) Burn 1 1
Adhesion(s) 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
Sedation 1 1
Pain 1 1
Crushing Injury 1 1
Partial thickness (Second Degree) Burn 1 1
Hematoma 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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