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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 371 371

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1123 1123
Power Problem 392 392
Unstable 353 353
Patient Device Interaction Problem 275 275
Intermittent Loss of Power 249 249
Gas/Air Leak 223 223
Appropriate Term/Code Not Available 203 203
Material Frayed 158 158
Calibration Problem 140 140
Mechanical Problem 109 109
Component Missing 91 91
Noise, Audible 90 90
Failure to Power Up 84 84
Incorrect, Inadequate or Imprecise Result or Readings 81 81
Material Deformation 76 76
Loss of Power 69 69
Output Problem 63 63
Naturally Worn 61 61
Corroded 57 57
Break 53 53
Insufficient Information 52 52
Physical Resistance/Sticking 52 52
Loose or Intermittent Connection 49 49
Fitting Problem 46 46
Electrical /Electronic Property Problem 42 42
Adverse Event Without Identified Device or Use Problem 34 34
Incorrect Measurement 32 32
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 20 20
Detachment of Device or Device Component 15 15
Electrical Power Problem 14 14
Dull, Blunt 13 13
Overheating of Device 12 12
Unexpected Shutdown 11 11
Activation Problem 11 11
Pressure Problem 11 11
Fluid/Blood Leak 8 8
Degraded 7 7
Connection Problem 7 7
Failure to Calibrate 7 7
Misassembled 6 6
Mechanical Jam 6 6
Complete Loss of Power 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
Material Puncture/Hole 5 5
Defective Component 4 4
Delivered as Unsterile Product 4 4
Excessive Heating 4 4
Temperature Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
Leak/Splash 3 3
Output above Specifications 3 3
Positioning Failure 3 3
Circuit Failure 3 3
Difficult to Remove 3 3
Device Damaged Prior to Use 3 3
Improper Flow or Infusion 3 3
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
Device Reprocessing Problem 2 2
Unintended Power Up 2 2
Gel Leak 2 2
Imprecision 2 2
Off-Label Use 2 2
Unintended Movement 2 2
Misassembly by Users 2 2
Mechanics Altered 2 2
Key or Button Unresponsive/not Working 2 2
Failure to Clean Adequately 1 1
Illegible Information 1 1
Unclear Information 1 1
Missing Information 1 1
Audible Prompt/Feedback Problem 1 1
Device Fell 1 1
Explosion 1 1
Packaging Problem 1 1
Device Handling 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1982 1982
No Patient Involvement 332 332
No Consequences Or Impact To Patient 263 263
Laceration(s) 246 246
No Known Impact Or Consequence To Patient 219 219
Abrasion 175 175
Insufficient Information 71 71
Unspecified Tissue Injury 49 49
No Code Available 42 42
Injury 15 15
Scar Tissue 15 15
Localized Skin Lesion 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Physical Asymmetry 5 5
Skin Tears 5 5
Muscle/Tendon Damage 4 4
No Information 3 3
Impaired Healing 3 3
Suture Abrasion 3 3
Burn(s) 3 3
Scarring 2 2
Tissue Damage 2 2
Tissue Breakdown 2 2
Failure of Implant 2 2
Patient Problem/Medical Problem 2 2
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
Sedation 1 1
Wrinkling 1 1
Crushing Injury 1 1
Hair Loss 1 1
Hematoma 1 1
Adhesion(s) 1 1
Pain 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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