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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 461 461

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 956 956
Power Problem 330 330
Unstable 196 196
Gas/Air Leak 191 191
Intermittent Loss of Power 190 190
Device Operates Differently Than Expected 136 136
Material Frayed 133 133
Mechanical Problem 98 98
Loss of Power 93 93
Output Problem 82 82
Patient Device Interaction Problem 77 77
Calibration Problem 77 77
Incorrect, Inadequate or Imprecise Result or Readings 74 74
Component Missing 66 66
Noise, Audible 61 61
Incorrect Measurement 59 59
Failure to Power Up 53 53
Material Deformation 47 47
Appropriate Term/Code Not Available 46 46
Fitting Problem 41 41
Electrical /Electronic Property Problem 33 33
Adverse Event Without Identified Device or Use Problem 32 32
Output below Specifications 31 31
Corroded 31 31
Break 28 28
Naturally Worn 27 27
Insufficient Information 26 26
Air Leak 24 24
Physical Resistance/Sticking 23 23
Loose or Intermittent Connection 22 22
Structural Problem 21 21
Material Split, Cut or Torn 13 13
Material Integrity Problem 12 12
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
Electrical Power Problem 8 8
Overheating of Device 8 8
Misassembled 8 8
Fluid/Blood Leak 8 8
Use of Device Problem 7 7
Pressure Problem 7 7
Positioning Problem 6 6
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
Dull, Blunt 5 5
Defective Device 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
Failure to Obtain Sample 4 4
Connection Problem 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
Failure to Shut Off 3 3
Temperature Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Excessive Heating 3 3
Complete Loss of Power 3 3
Device Contamination with Chemical or Other Material 2 2
Expulsion 2 2
Manufacturing, Packaging or Shipping Problem 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
Unexpected Therapeutic Results 2 2
Device Operational Issue 2 2
Sparking 2 2
Malposition of Device 2 2
Device Issue 2 2
Obstruction of Flow 1 1
Blocked Connection 1 1
Difficult to Advance 1 1
Difficult to Open or Close 1 1
Activation, Positioning or Separation 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
Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 929 929
No Consequences Or Impact To Patient 483 483
No Known Impact Or Consequence To Patient 423 423
No Patient Involvement 392 392
Abrasion 273 273
Laceration(s) 100 100
No Code Available 90 90
Insufficient Information 46 46
Injury 33 33
No Information 29 29
Tissue Damage 24 24
Suture Abrasion 15 15
Unspecified Tissue Injury 12 12
Scar Tissue 10 10
Localized Skin Lesion 8 8
Scarring 6 6
Skin Tears 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Burn(s) 3 3
Hematoma 3 3
Unspecified Infection 2 2
Pain 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
Complaint, Ill-Defined 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1
Fluid Discharge 1 1
Perforation of Vessels 1 1
Skin Irritation 1 1
Sprain 1 1
Wound Dehiscence 1 1
Failure of Implant 1 1
Crushing Injury 1 1
Adhesion(s) 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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