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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
2017 324 324
2018 378 378
2019 472 472
2020 433 433
2021 614 614
2022 313 313

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 923 923
Power Problem 317 317
Unstable 189 189
Gas Leak 180 180
Intermittent Loss of Power 172 172
Device Operates Differently Than Expected 136 136
Material Frayed 127 127
Loss of Power 93 93
Output Problem 80 80
Mechanical Problem 77 77
Incorrect, Inadequate or Imprecise Resultor Readings 71 71
Patient Device Interaction Problem 70 70
Calibration Problem 65 65
Component Missing 58 58
Incorrect Measurement 58 58
Noise, Audible 54 54
Failure to Power Up 44 44
Appropriate Term/Code Not Available 40 40
Material Deformation 38 38
Fitting Problem 38 38
Output below Specifications 31 31
Adverse Event Without Identified Device or Use Problem 30 30
Electrical /Electronic Property Problem 25 25
Break 25 25
Air Leak 24 24
Corroded 24 24
Naturally Worn 21 21
Physical Resistance/Sticking 18 18
Structural Problem 18 18
Loose or Intermittent Connection 17 17
Insufficient Information 17 17
Material Split, Cut or Torn 13 13
Material Integrity Problem 11 11
Device Contaminated During Manufacture or Shipping 11 11
Vibration 11 11
Device Stops Intermittently 9 9
Mechanics Altered 9 9
Material Twisted/Bent 8 8
Failure to Calibrate 8 8
Overheating of Device 8 8
Fluid Leak 8 8
Use of Device Problem 7 7
Electrical Power Problem 7 7
Pressure Problem 7 7
Misassembly by Users 6 6
Improper or Incorrect Procedure or Method 6 6
Device Damaged Prior to Use 6 6
Device Inoperable 6 6
Degraded 6 6
Misassembled 6 6
Defective Device 5 5
Positioning Problem 5 5
Electrical Shorting 5 5
Mechanical Jam 5 5
Improper Device Output 5 5
Unexpected Shutdown 5 5
Detachment of Device or Device Component 4 4
Dull, Blunt 4 4
Failure to Obtain Sample 4 4
Defective Component 4 4
Difficult to Remove 4 4
Leak/Splash 4 4
Output above Specifications 4 4
Device Emits Odor 3 3
Partial Blockage 3 3
Imprecision 3 3
Flaked 3 3
Circuit Failure 3 3
Connection Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Excessive Heating 3 3
Complete Loss of Power 3 3
Temperature Problem 2 2
Expulsion 2 2
Failure to Shut Off 2 2
Device Contamination with Chemical or Other Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Operational Issue 2 2
Device Issue 2 2
Sparking 2 2
Malposition of Device 2 2
Fracture 2 2
Gel Leak 2 2
Positioning Failure 2 2
Unintended Power Up 2 2
Burst Container or Vessel 2 2
Delivered as Unsterile Product 2 2
Unintended System Motion 2 2
Energy Output Problem 2 2
No Device Output 1 1
Decrease in Pressure 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Inflation Problem 1 1
Calibration Error 1 1
Bent 1 1
Material Fragmentation 1 1
Device Reprocessing Problem 1 1
Use of Incorrect Control Settings 1 1
Restricted Flow rate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 798 798
No Consequences Or Impact To Patient 483 483
No Known Impact Or Consequence To Patient 423 423
No Patient Involvement 392 392
Abrasion 266 266
Laceration(s) 97 97
No Code Available 90 90
Insufficient Information 35 35
Injury 33 33
No Information 29 29
Tissue Damage 24 24
Suture Abrasion 15 15
Scar Tissue 10 10
Localized Skin Lesion 8 8
Unspecified Tissue Injury 8 8
Scarring 6 6
Skin Tears 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Hematoma 3 3
Burn(s) 3 3
Unspecified Infection 2 2
Pain 2 2
Patient Problem/Medical Problem 2 2
Impaired Healing 2 2
Wound Dehiscence 1 1
Sedation 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
Fluid Discharge 1 1
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
Crushing Injury 1 1
Adhesion(s) 1 1
Skin Irritation 1 1
Sprain 1 1
Perforation of Vessels 1 1
Complaint, Ill-Defined 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exsurco Medical II Jun-26-2018
2 Integra LifeSciences Corp. II Sep-12-2020
3 Zimmer Surgical Inc II Aug-03-2018
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